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1. Trends in chronic hepatitis B virus infection in Italy over a 10-year period: Clues from the nationwide PITER and MASTER cohorts toward elimination

Author

Giuseppina Brancaccio, Barbara Coco, Alessandra Nardi, Maria Giovanna Quaranta, Maria Elena Tosti, Luigina Ferrigno, Irene Cacciola, Vincenzo Messina, Luchino Chessa, Filomena Morisco, Michele Milella, Francesco Barbaro, Alessia Ciancio, Francesco Paolo Russo, Nicola Coppola, Pierluigi Blanc, Ernesto Claar, Gabriella Verucchi, Massimo Puoti, Anna Linda Zignego, Liliana Chemello, Salvatore Madonia, Stefano Fagiuoli, Alfredo Marzano, Carlo Ferrari, Pietro Lampertico, Vito Di Marco, Antonio Craxì, Teresa Antonia Santantonio, Giovanni Raimondo, Maurizia R. Brunetto, Giovanni Battista Gaeta, Loreta A. Kondili, Luisa Pasulo, Carmine Coppola, Federica Pisano, Mariarosaria Romano, Carmen Porcu, Irene Francesca Bottalico, Valentina Cossiga, Xhimi Tata, Caterina Sagnelli, Piera Pierotti, Elisabetta Degasperi, Valerio Rosato, Lorenzo Badia, Dontella Ieluzzi, Monica Monti, Maria Grazia Bavetta, Luisa Cavalletto, Pierluigi Toniutto, Ezio Fornasiere, Antonio Colecchia, Alberto Ferrarese, Gerardo Nardone, Alba Rocco, Mauro Viganò, Francesco Giuseppe Foschi, Fabio Conti, Giulia Morsica, Stefania Salpietro, Carlo Torti, Chiara Costa, Alessandro Federico, Marcello Dallio, Alessia Giorgini, Marco Anselmo, Pasqualina De Leo, Serena Zaltron, Anna Cambianica, Fabio Piscaglia, Ilaria Serio, Simona Schivazappa, Antonio Mastroianni, Luciana Chidichimo, Marco Massari, Cesare Mazzaro, Aldo Marrone, Francesca Maria D'Amore, Gianpiero D'Offizi, Anna Licata, Grazia Anna Niro, Teresa Pollicino, and Alessio Aghemo

Subjects
Hepatitis B, Chronic, Hepatitis Delta, Epidemiology, Migrants, Hepatitis control, Infectious and parasitic diseases, RC109-216
Abstract

Objectives: The study measures trends in the profile of patients with chronic hepatitis B virus linked to care in Italy. Methods: A cross-sectional, multicenter, observational cohort (PITER cohort) of consecutive patients with hepatitis B surface antigen (HBsAg) over the period 2019-2021 from 46 centers was evaluated. The reference was the MASTER cohort collected over the years 2012-2015. Standard statistical methods were used. Results: The PITER cohort enrolled 4583 patients, of whom 21.8% were non-Italian natives. Compared with those in MASTER, the patients were older and more often female. The prevalence of hepatitis B e antigen (HBeAg) declined (7.2% vs 12.3; P

Published
2023
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2. Dysmetabolism, Diabetes and Clinical Outcomes in Patients Cured of Chronic Hepatitis C: A Real‐Life Cohort Study

Author

Luca Valenti, Serena Pelusi, Alessio Aghemo, Sara Gritti, Luisa Pasulo, Cristiana Bianco, Claudia Iegri, Giuliana Cologni, Elisabetta Degasperi, Roberta D’Ambrosio, Paolo delPoggio, Alessandro Soria, Massimo Puoti, Isabella Carderi, Marie Graciella Pigozzi, Canio Carriero, Angiola Spinetti, Valentina Zuccaro, Massimo Memoli, Alessia Giorgini, Mauro Viganò, Maria Grazia Rumi, Tiziana Re, Ombretta Spinelli, Maria Chiara Colombo, Tiziana Quirino, Barbara Menzaghi, Gianpaolo Lorini, Angelo Pan, Antonella D’Arminio Monforte, Elisabetta Buscarini, Aldo Autolitano, Paolo Bonfanti, Natalia Terreni, Gianpiero Aimo, Monia Mendeni, Daniele Prati, Pietro Lampertico, Massimo Colombo, Stefano Fagiuoli, and for the NAVIGATORE‐Lombardia Network

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

The aim of this study was to examine the impact of features of dysmetabolism on liver disease severity, evolution, and clinical outcomes in a real‐life cohort of patients treated with direct acting antivirals for chronic hepatitis C virus (HCV) infection. To this end, we considered 7,007 patients treated between 2014 and 2018, 65.3% with advanced fibrosis, of whom 97.7% achieved viral eradication (NAVIGATORE‐Lombardia registry). In a subset (n = 748), liver stiffness measurement (LSM) was available at baseline and follow‐up. Higher body mass index (BMI; odds ratio [OR] 1.06 per kg/m2, 1.03‐1.09) and diabetes (OR 2.01 [1.65‐2.46]) were independently associated with advanced fibrosis at baseline, whereas statin use was protective (OR 0.46 [0.35‐0.60]; P

Published
2022
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3. Liver function following hepatitis C virus eradication by direct acting antivirals in patients with liver cirrhosis: data from the PITER cohort

Author

Maria Giovanna Quaranta, Luigina Ferrigno, Xhimi Tata, Franca D’Angelo, Carmine Coppola, Alessia Ciancio, Serena Rita Bruno, Martina Loi, Alessia Giorgini, Marzia Margotti, Valentina Cossiga, Giuseppina Brancaccio, Marcello Dallio, Martina De Siena, Marco Cannizzaro, Luisa Cavalletto, Marco Massari, Maria Mazzitelli, Pasqualina De Leo, Diletta Laccabue, Leonardo Baiocchi, and Loreta A. Kondili

Subjects
Hepatitis C virus, Human immunodeficiency virus, Real-life cohort, Direct-acting antivirals, Advanced liver disease, Decompensated cirrhosis, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background The development of direct-acting antivirals (DAA) for HCV has revolutionized the treatment of HCV, including its treatment in patients with HIV coinfection. The aim of this study was to compare the changes in liver function between coinfected and monoinfected patients with cirrhosis who achieved HCV eradication by DAA. Methods Patients with pre-treatment diagnosis of HCV liver cirrhosis, consecutively enrolled in the multicenter PITER cohort, who achieved a sustained virological response 12 weeks after treatment cessation (SVR12) were analysed. Changes in Child-Pugh (C-P) class and the occurrence of a decompensating event was prospectively evaluated after the end of DAA treatment. Cox regression analysis was used to evaluate factors independently associated with changes in liver function following viral eradication. Results We evaluated 1350 patients, of whom 1242 HCV monoinfected (median follow-up 24.7, range 6.8–47.5 months after viral eradication) and 108 (8%) HCV/HIV coinfected (median follow-up 27.1, range 6.0–44.6). After adjusting for age, sex, HCV-genotype, HBsAg positivity and alcohol use, HIV was independently associated with a more advanced liver disease before treatment (C-P class B/C vs A) (OR: 3.73, 95% CI:2.00–6.98). Following HCV eradication, C-P class improved in 17/20 (85%) coinfected patients (from B to A and from C to B) and in 53/82 (64.6%) monoinfected patients (from B to A) (p = 0.08). C-P class worsened in 3/56 coinfected (5.3%) (from A to B) and in 84/1024 (8.2%) monoinfected patients (p = 0.45) (from A to B or C and from B to C). Baseline factors independently associated with C-P class worsening were male sex (HR = 2.00; 95% CI = 1.18–3.36), platelet count

Published
2021
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4. SARS‐CoV‐2–related ARDS in a maintenance hemodialysis patient: case report on tailored approach by daily hemodialysis, noninvasive ventilation, tocilizumab, anxiolytics, and point‐of‐care ultrasound

Author

Andrea Galassi, Francesca Casanova, Lidia Gazzola, Rocco Rinaldo, Marco Ceresa, Elena Restelli, Alessia Giorgini, Simone Birocchi, Marco Giovenzana, Ulisse Zoni, Federica Valli, Laura Massironi, Sebastiano Belletti, Lorenza Magagnoli, Andrea Stucchi, Michela Ippolito, Stefano Carugo, Elena Parazzini, and Mario Cozzolino

Subjects
COVID‐19, expanded hemodialysis, hemodialysis, point‐of‐care ultrasound, suprahepatic veins venogram, tocilizumab, Medicine, Medicine (General), R5-920
Abstract

Abstract Without rescue drugs approved, holistic approach by daily hemodialysis, noninvasive ventilation, anti‐inflammatory medications, fluid assessment by bedside ultrasound, and anxiolytics improved outcomes of a maintenance hemodialysis patient affected by severe COVID‐19.

Published
2021
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5. Profiling the risk of hepatocellular carcinoma after long-term HCV eradication in patients with liver cirrhosis in the PITER cohort

Author

Loreta A. Kondili, Maria Giovanna Quaranta, Luisa Cavalletto, Vincenza Calvaruso, Luigina Ferrigno, Roberta D'Ambrosio, Ilaria Simonelli, Giuseppina Brancaccio, Giovanni Raimondo, Maurizia R. Brunetto, Anna Linda Zignego, Carmine Coppola, Andrea Iannone, Elisa Biliotti, Gabriella Verucchi, Marco Massari, Anna Licata, Francesco Barbaro, Marcello Persico, Francesco Paolo Russo, Filomena Morisco, Maurizio Pompili, Mauro Viganò, Massimo Puoti, Teresa Santantonio, Erica Villa, Antonio Craxì, Liliana Chemello, Valentina Panetta, Giovanni Battista Gaeta, Roberto Filomia, Barbara Coco, Monica Monti, Daniela Caterina Amoruso, Salvatore Madonia, Donatella Ieluzzi, Gloria Taliani, Lorenzo Badia, Guglielmo Marco Migliorino, Alessia Giorgini, Mario Masarone, Pierluigi Blanc, Valentina Cossiga, Martina De Siena, Xhimi Tata, Maria Grazia Rumi, Luchino Chessa, Pietro Lampertico, Carlo Ferrari, Ivan Gentile, Giustino Parruti, Leonardo Baiocchi, Alessia Ciancio, Pietro Invernizzi, Alessandro Federico, Carlo Torti, Giulia Morsica, Pietro Andreone, Alessio Aghemo, Patrizia Popoli, Stefano Vella, Kondili, L. A., Quaranta, M. G., Cavalletto, L., Calvaruso, V., Ferrigno, L., D'Ambrosio, R., Simonelli, I., Brancaccio, G., Raimondo, G., Brunetto, M. R., Zignego, A. L., Coppola, C., Iannone, A., Biliotti, E., Verucchi, G., Massari, M., Licata, A., Barbaro, F., Persico, M., Russo, F. P., Morisco, F., Pompili, M., Vigano, M., Puoti, M., Santantonio, T., Villa, E., Craxi, A., Chemello, L., Panetta, V., Gaeta, G. B., Filomia, R., Coco, B., Monti, M., Amoruso, D. C., Madonia, S., Ieluzzi, D., Taliani, G., Badia, L., Migliorino, G. M., Giorgini, A., Masarone, M., Blanc, P., Cossiga, V., De Siena, M., Tata, X., Rumi, M. G., Chessa, L., Lampertico, P., Ferrari, C., Gentile, I., Parruti, G., Baiocchi, L., Ciancio, A., Invernizzi, P., Federico, A., Torti, C., Morsica, G., Andreone, P., Aghemo, A., Popoli, P., Vella, S., Kondili, Loreta A, Quaranta, Maria Giovanna, Cavalletto, Luisa, Calvaruso, Vincenza, Ferrigno, Luigina, D'Ambrosio, Roberta, Simonelli, Ilaria, Brancaccio, Giuseppina, Raimondo, Giovanni, Brunetto, Maurizia R, Zignego, Anna Linda, Coppola, Carmine, Iannone, Andrea, Biliotti, Elisa, Verucchi, Gabriella, Massari, Marco, Licata, Anna, Barbaro, Francesco, Persico, Marcello, Russo, Francesco Paolo, Morisco, Filomena, Pompili, Maurizio, Viganò, Mauro, Puoti, Massimo, Santantonio, Teresa, Villa, Erica, Craxì, Antonio, and Chemello, Liliana

Subjects
Settore MED/12, Real-life cohort, Hepatology, Direct-acting antiviral, HCC, Long term outcomes, Predictive factors, Gastroenterology, Long term outcome, Predictive factor
Abstract

Background and aims: Severe liver disease markers assessed before HCV eradication are acknowledged to usually improve after the SVR. We prospectively evaluated, in the PITER cohort, the long-term HCC risk profile based on predictors monitored after HCV eradication by direct-acting antivirals in patients with cirrhosis. Methods: HCC occurrence was evaluated by Kaplan-Meier analysis. Cox regression analysis identified the post-treatment variables associated with de-novo HCC; their predictive power was presented in a nomogram. Results: After the end of therapy (median follow-up:28.47 months), among 2064 SVR patients, 119 (5.8%) developed de-novo HCC. The HCC incidence was 1.90%, 4.21%, 6.47% at 12-, 24- and 36-months from end-of-therapy, respectively (incidence rate 2.45/100 person-years). Age, genotype 3, diabetes, platelets (PLT)≤120,000/µl and albumin ≤3.5g/dl levels were identified as pre-treatment HCC independent predictors. Adjusting for age, the post-treatment PLT≤120,000/µl (AdjHR 1.92; 95%CI:1.06-3.45) and albumin≤3.5g/dl (AdjHR 4.38; 95%CI 2.48-7.75) values were independently associated with HCC occurrence. Two different risk profiles were identified by combining long-term post-therapy evaluation of PLT ≤ vs. >120,000/µl and albumin ≤ vs. >3.5g/dl showing a significant different HCC incidence rate of 1.35 vs. 3.77/100 p-y, respectively. Conclusions: The nomogram score based on age, PLT and albumin levels after SVR showed an accurate prediction capability and may support the customizing management for early HCC detection.

Published
2023

6. Trientine tetrahydrochloride versus penicillamine for maintenance therapy in Wilson disease (CHELATE):a randomised, open-label, non-inferiority, phase 3 trial

Author

Michael L Schilsky, Anna Czlonkowska, Massimo Zuin, David Cassiman, Carlos Twardowschy, Aurelia Poujois, Francisco de Assis A Gondim, Gerald Denk, Rubens G Cury, Peter Ott, Joanna Moore, Aftab Ala, Renata D'Inca, Eduardo Couchonnal-Bedoya, Koenraad D'Hollander, Nicolas Dubois, C Omar F Kamlin, Karl Heinz Weiss, Uyen To, Amar Patel, Daksshi Hettiarachchi, Alessia Giorgini, Sara Monico, Tomasz Litwin, Agnieszka Piechal, Marta Skowronska, Alain Lachaux, Abdelouahed Belmalih, Alexandra Boogers, Isabelle Mohr, Andrea Langel, Christian Freitas, Egberto Reis Barbosa, Thomas D Sandahl, Lisbet Gerdes, Alexandre Obadia, Djamila Rahli, and Jeremy Cosgrove

Subjects
Adult, Hepatology, Hepatolenticular Degeneration, Penicillamine, Gastroenterology, Humans, Trientine, Copper, Chelating Agents
Abstract

Background: Wilson disease is an inherited disorder of copper transport. Whereas penicillamine is used therapeutically to re-establish copper balance, trientine is indicated for patients with penicillamine intolerance. We aimed to compare penicillamine with trientine tetrahydrochloride (TETA4) for maintenance therapy in patients with Wilson disease. Methods: We conducted a randomised, open-label, non-inferiority, phase 3 trial at 15 health-care centres across nine countries (patients were recruited from 13 of these health-care centres across Brazil, Europe, and the USA). We enrolled patients aged 18–75 years with stable Wilson disease who were treated for at least 1 year with penicillamine. Patients entered a 12-week period to determine stability through clinical assessment by site investigators and predefined thresholds for serum non-caeruloplasmin-bound copper (NCC; by an exchangeable copper assay; 25–150 μg/L), 24 h urinary copper excretion (100–900 μg/24 h), and alanine aminotransferase (ALT

Published
2022

7. Directly acting antivirals are safe and effective in HCV positive patients aged 80 years and older: a multicenter real-life study

Author

Arianna Dal Buono, Rossella Meli, Federica Lubrano Lobianco, Nicola Pugliese, Massimo Zuin, Alessio Aghemo, Pier Maria Battezzati, Adriano De Santis, Daniela Maggi, Alessia Giorgini, Clara Dibenedetto, Ana Lleo, Antonio Capogreco, and S. Monico

Subjects
Liver Cirrhosis, Male, medicine.medical_specialty, Genotype, Sustained Virologic Response, Hepacivirus, 030204 cardiovascular system & hematology, elderly, Antiviral Agents, HCV Positive, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Chronic hepatitis, Internal medicine, antiviral therapy, 80 and over, medicine, Humans, Drug Interactions, Pharmacology (medical), tolerability, hepatitis c, Retrospective Studies, Aged, 80 and over, drug interaction, business.industry, Antiviral therapy, food and beverages, General Medicine, Hepatitis C, Chronic, Drug interaction, chronic, aged, Tolerability, 030220 oncology & carcinogenesis, Virologic response, HCV, aged, 80 and over, antiviral agents, cohort studies, drug interactions, female, follow-up studies, genotype, hepacivirus, humans, liver cirrhosis, male, retrospective studies, sustained virologic response, Female, Life study, business, Follow-Up Studies
Abstract

Background: Treatment of chronic Hepatitis C with directly acting antivirals (DAAs) can bring to sustained virologic response (SVR) in approximately 95% of patients. Efficacy and safety of DAAs in ...

Published
2021

8. SARS‐CoV‐2–related ARDS in a maintenance hemodialysis patient: case report on tailored approach by daily hemodialysis, noninvasive ventilation, tocilizumab, anxiolytics, and point‐of‐care ultrasound

Author

Stefano Carugo, Laura Massironi, Lorenza Magagnoli, Alessia Giorgini, U. Zoni, Simone Birocchi, Francesca Casanova, Elena Maria Parazzini, Michela Ippolito, Rocco Francesco Rinaldo, Lidia Gazzola, Federica Valli, Marco Ceresa, Marco Giovenzana, S. Belletti, Mario Cozzolino, Andrea Galassi, Elena Restelli, and Andrea Stucchi

Subjects
ARDS, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), medicine.medical_treatment, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), lcsh:Medicine, Case Report, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, tocilizumab, 0302 clinical medicine, Tocilizumab, COVID‐19, expanded hemodialysis, medicine, point‐of‐care ultrasound, Intensive care medicine, lcsh:R5-920, hemodialysis, suprahepatic veins venogram, business.industry, Point of care ultrasound, lcsh:R, Maintenance hemodialysis, General Medicine, medicine.disease, chemistry, 030220 oncology & carcinogenesis, Noninvasive ventilation, Hemodialysis, business, lcsh:Medicine (General)
Abstract

Without rescue drugs approved, holistic approach by daily hemodialysis, noninvasive ventilation, anti‐inflammatory medications, fluid assessment by bedside ultrasound, and anxiolytics improved outcomes of a maintenance hemodialysis patient affected by severe COVID‐19.

Published
2021

9. Renal safety in 3264 HCV patients treated with DAA-based regimens: Results from a large Italian real-life study

Author

Alessandra Brocchieri, Marta Borghi, Angelo Pan, Mariella Di Marco, Silvia Colombo, Chiara Molteni, Natalia Terreni, Paolo Poggio, Alberto Colombo, De Silvestri Annalisa, Riccardo Centenaro, Luisa Pasulo, Paolo Viganò, Maria Cristina Vinci, Marie Graciella Pigozzi, Stefano Fagiuoli, Pietro Lampertico, Sergio Lazzaroni, Sherrie Bhoori, Massimo Zuin, Franco Noventa, Alessio Aghemo, Barbara Menzaghi, Andrea Lombardi, Franco Maggiolo, I. Fanetti, Alessia Giorgini, Massimo Puoti, Emanuela Messina, Paolo Grossi, Roberta D'Ambrosio, Pietro Invernizzi, Monia Mendeni, Daniele Bella, E. Dionigi, Ombretta Spinelli, Maria Teresa Taddei, Pietro Pozzoni, Antonella d'Arminio Monforte, Elisabetta Buscarini, Angiola Spinetti, Serena Zaltron, D'Ambrosio, R, Pasulo, L, Giorgini, A, Spinetti, A, Messina, E, Fanetti, I, Puoti, M, Aghemo, A, Vigano, P, Vinci, M, Menzaghi, B, Lombardi, A, Pan, A, Pigozzi, M, Grossi, P, Lazzaroni, S, Spinelli, O, Invernizzi, P, Maggiolo, F, Terreni, N, Monforte, A, Poggio, P, Taddei, M, Colombo, S, Pozzoni, P, Molteni, C, Brocchieri, A, Bhoori, S, Buscarini, E, Centenaro, R, Mendeni, M, Colombo, A, Di Marco, M, Dionigi, E, Bella, D, Borghi, M, Zuin, M, Zaltron, S, Noventa, F, Annalisa, D, Lampertico, P, and Fagiuoli, S

Subjects
Male, Sustained Virologic Response, Sofosbuvir, Hepacivirus, Kidney, urologic and male genital diseases, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, MED/12 - GASTROENTEROLOGIA, eGFR, Aged, 80 and over, Hepatitis C, Middle Aged, medicine.anatomical_structure, Italy, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Glomerular Filtration Rate, Cohort study, medicine.drug, Adult, medicine.medical_specialty, SVR, Genotype, Renal function, CKD, Antiviral Agents, Young Adult, 03 medical and health sciences, Internal medicine, medicine, Humans, Renal Insufficiency, Chronic, Aged, Retrospective Studies, Hepatology, business.industry, Ribavirin, Retrospective cohort study, Hepatitis C, Chronic, medicine.disease, Logistic Models, chemistry, business, Kidney disease
Abstract

Background: Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCV patients with estimated glomerular filtration rate (eGFR) ≤ 45 ml/min, but further investigations are lacking. Aim: To assess renal safety in a large cohort of DAA-treated HCV patients with any chronic kidney disease (CKD). Methods: All HCV patients treated with DAA in Lombardy (December 2014–November 2017) with available kidney function tests during and off-treatment were included. Results: Among 3264 patients [65% males, 67% cirrhotics, eGFR 88 (9–264) ml/min], CKD stage was 3 in 9.5% and 4/5 in 0.7%. 79% and 73% patients received SOF and RBV, respectively. During DAA, eGFR declined in CKD-1 (p < 0.0001) and CKD-2 (p = 0.0002) patients, with corresponding rates of CKD stage reduction of 25% and 8%. Conversely, eGFR improved in lower CKD stages (p < 0.0001 in CKD-3a, p = 0.0007 in CKD-3b, p = 0.024 in CKD-4/5), with 33–45% rates of CKD improvement. Changes in eGFR and CKD distribution persisted at SVR. Baseline independent predictors of CKD worsening at EOT and SVR were age (p < 0.0001), higher baseline CKD stages (p < 0.0001) and AH (p = 0.010 and p < 0.0001, respectively). Conclusions: During DAA, eGFR significantly declined in patients with preserved renal function and improved in those with lower CKD stages, without reverting upon drug discontinuation.

Published
2020

10. Dysmetabolism, Diabetes and Clinical Outcomes in Patients Cured of Chronic Hepatitis C: A Real-Life Cohort Study

Author

Gianpaolo Lorini, Roberta D'Ambrosio, Monia Mendeni, Angelo Pan, Valentina Zuccaro, Canio Carriero, Massimo Colombo, Gianpiero Aimo, Natalia Terreni, Barbara Menzaghi, Massimo Memoli, Alessandro Soria, Aldo Autolitano, Elisabetta Degasperi, Serena Pelusi, M. Puoti, Luca Valenti, Cristiana Bianco, Ombretta Spinelli, Elisabetta Buscarini, Antonella d'Arminio Monforte, Sara Gritti, Paolo Del Poggio, Alessia Giorgini, Tiziana Quirino, T. Re, Marie Graciella Pigozzi, Maria Grazia Rumi, Maria Chiara Colombo, Giuliana Cologni, Daniele Prati, Angiola Spinetti, Stefano Fagiuoli, Mauro Viganò, Isabella Carderi, Luisa Pasulo, Pietro Lampertico, Alessio Aghemo, Paolo Bonfanti, C. Iegri, Valenti, L, Pelusi, S, Aghemo, A, Gritti, S, Pasulo, L, Bianco, C, Iegri, C, Cologni, G, Degasperi, E, D'Ambrosio, R, del Poggio, P, Soria, A, Puoti, M, Carderi, I, Pigozzi, M, Carriero, C, Spinetti, A, Zuccaro, V, Memoli, M, Giorgini, A, Vigano, M, Rumi, M, Re, T, Spinelli, O, Colombo, M, Quirino, T, Menzaghi, B, Lorini, G, Pan, A, D'Arminio Monforte, A, Buscarini, E, Autolitano, A, Bonfanti, P, Terreni, N, Aimo, G, Mendeni, M, Prati, D, Lampertico, P, and Fagiuoli, S

Subjects
Liver Cirrhosis, medicine.medical_specialty, Carcinoma, Hepatocellular, Sustained Virologic Response, Chronic liver disease, Gastroenterology, Antiviral Agents, Cohort Studies, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Internal medicine, Diabetes mellitus, Diabetes Mellitus, Medicine, Humans, 2. Zero hunger, Hepatology, business.industry, Hazard ratio, Liver Neoplasms, Odds ratio, Hepatitis C, Chronic, medicine.disease, 3. Good health, Metformin, Cardiovascular Diseases, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, HCV, 030211 gastroenterology & hepatology, business, Body mass index, medicine.drug
Abstract

The aim of this study was to examine the impact of features of dysmetabolism on liver disease severity, evolution, and clinical outcomes in a real-life cohort of patients treated with direct acting antivirals for chronic hepatitis C virus (HCV) infection. To this end, we considered 7,007 patients treated between 2014 and 2018, 65.3% with advanced fibrosis, of whom 97.7% achieved viral eradication (NAVIGATORE-Lombardia registry). In a subset (n=748), liver stiffness measurement (LSM) was available at baseline and follow-up. Higher body mass index (BMI; odds ratio [OR] 1.06 per kg/m2, 1.03-1.09) and diabetes (OR 2.01 [1.65-2.46]) were independently associated with advanced fibrosis at baseline, whereas statin use was protective (OR 0.46 [0.35-0.60]; P&nbsp

Published
2021

11. Clinical features and comorbidity pattern of HCV infected migrants compared to native patients in care in Italy: A real-life evaluation of the PITER cohort

Author

Maria Giovanna Quaranta, Luigina Ferrigno, Xhimi Tata, Franca D'Angelo, Marco Massari, Carmine Coppola, Elisa Biliotti, Alessia Giorgini, Diletta Laccabue, Alessia Ciancio, Pier Luigi Blanc, Marzia Margotti, Donatella Ieluzzi, Maurizia Rossana Brunetto, Francesco Barbaro, Francesco Paolo Russo, Ilaria Beretta, Giulia Morsica, Gabriella Verucchi, Annalisa Saracino, Massimo Galli, Loeta A. Kondili, Cesare Mazzaro, Manuela Bertola, Ornella Schioppa, Antonio Benedetti, Laura Schiadà, Monica Cucco, Andrea Giacometti, Laura Brescini, Sefora Castelletti, Alessandro Fiorentini, Gioacchino Angarano, Michele Milella, Alfredo Di Leo, Maria Rendina, Fulvio Salvatore D'abramo, Chiara Lillo, Andrea Iannone, Mariano Piazzolla, Lorenzo Badia, Fabio Piscaglia, Francesca Benevento, Ilaria Serio, Francesco Castelli, Serena Zaltron, Angiola Spinetti, Silvia Odolini, Raffaele Bruno, Mario Mondelli, Luchino Chessa, Martina Loi, Carlo Torti, Chiara Costa, Maria Mazzitelli, Vincenzo Pisani, Vincenzo Scaglione, Enrico Maria Trecarichi, Anna Linda Zignego, Monica Monti, Francesco Madia, Letizia Attala, Piera Pierotti, Elena Salomoni, Elisa Mariabelli, Teresa Antonia Santantonio, Serena Rita Bruno, Ester Marina Cela, Matteo Bassetti, Giovanni Mazzarello, Anna Ida Alessandrini, Antonio Di Biagio, Laura Ambra Nicolini, Giovanni Raimondo, Roberto Filomia, Alessio Aghemo, Rossella Meli, Adriano Lazzarin, Stefania Salpietro, Anna Ludovica Fracanzani, Erika Fatta, Rosa Lombardi, Pietro Lampertico, Marta Borghi, Roberta D'ambrosio, Elisabetta Degasperi, Massimo Puoti, Chiara Baiguera, Federico D'amico, Maria Vinci, Maria Grazia Rumi, Massimo Zuin, Paola Zermiani, Pietro Andreone, Paolo Caraceni, Valeria Guarneri, Erica Villa, Veronica Bernabucci, Laura Bristot, Maria Luisa Paradiso, Guglielmo Migliorino, Alessandra Gambaro, Giuseppe Lapadula, Anna Spolti, Alessandro Soria, Pietro Invernizzi, Antonio Ciaccio, Martina LucÀ, Federica Malinverno, Laura Ratti, Daniela Caterina Amoruso, Federica Pisano, Ferdinando Scarano, Laura Staiano, Filomena Morisco, Valentina Cossiga, Ivan Gentile, Antonio Riccardo Buonomo, Maria Foggia, Emanuela Zappulo, Alessandro Federico, Marcello Dallio, Nicola Coppola, Caterina Sagnelli, Salvatore Martini, Caterina Monari, Gerardo Nardone, Costantino Sgamato, Liliana Chemello, Luisa Cavalletto, Daniela Sterrantino, Alberto Zanetto, Paola Zanaga, Giuseppina Brancaccio, Antonio Craxì, Salvatore Petta, Vincenza Calvaruso, Luciano Crapanzano, Salvatore Madonia, Marco Cannizzaro, Erica Maria Bruno, Anna Licata, Simona Amodeo, Adele Rosaria Capitano, Carlo Ferrari, Elisa Negri, Alessandra Orlandini, Marco Pesci, Roberto Gulminetti, Layla Pagnucco, Giustino Parruti, Paola Di Stefano, Barbara Coco, Romina Corsini, Elisa Garlassi, Massimo Andreoni, Elisabetta Teti, Carlotta Cerva, Lorenzo Baiocchi, Giuseppe Grassi, Antonio Gasbarrini, Maurizio Pompili, Martina De Siena, Gloria Taliani, Martina Spaziante, Marcello Persico, Mario Masarone, Andrea Aglitti, Gemma Calvanese, Marco Anselmo, Pasqualina De Leo, Monica Marturano, Giorgio Maria Saracco, Quaranta M.G., Ferrigno L., Tata X., D'Angelo F., Massari M., Coppola C., Biliotti E., Giorgini A., Laccabue D., Ciancio A., Blanc P.L., Margotti M., Ieluzzi D., Brunetto M.R., Barbaro F., Russo F.P., Beretta I., Morsica G., Verucchi G., Saracino A., Galli M., Kondili L.A., Mazzaro C., Bertola M., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Fiorentini A., Angarano G., Milella M., Leo A.D., Rendina M., Salvatore D'ABRAMO F., Lillo C., Iannone A., Piazzolla M., Badia L., Piscaglia F., Benevento F., Serio I., Castelli F., Zaltron S., Spinetti A., Odolini S., Bruno R., Mondelli M., Chessa L., Loi M., Torti C., Costa C., Mazzitelli M., Pisani V., Scaglione V., Trecarichi E.M., Zignego A.L., Monti M., Madia F., Attala L., Pierotti P., Salomoni E., Mariabelli E., Santantonio T.A., Bruno S.R., Cela E.M., Bassetti M., Mazzarello G., Alessandrini A.I., Biagio A.D., Nicolini L.A., Raimondo G., Filomia R., Aghemo A., Meli R., Lazzarin A., Salpietro S., Fracanzani A.L., Fatta E., Lombardi R., Lampertico P., Borghi M., D'ambrosio R., Degasperi E., Puoti M., Baiguera C., D'AMICO F., Vinci M., Rumi M.G., Zuin M., Zermiani P., Andreone P., Caraceni P., Guarneri V., Villa E., Bernabucci V., Bristot L., Paradiso M.L., Migliorino G., Gambaro A., Lapadula G., Spolti A., Soria A., Invernizzi P., Ciaccio A., LucA M., Malinverno F., Ratti L., Amoruso D.C., Pisano F., Scarano F., Staiano L., Morisco F., Cossiga V., Gentile I., Buonomo A.R., Foggia M., Zappulo E., Federico A., Dallio M., Coppola N., Sagnelli C., Martini S., Monari C., Nardone G., Sgamato C., Chemello L., Cavalletto L., Sterrantino D., Zanetto A., Zanaga P., Brancaccio G., Craxi A., Petta S., Calvaruso V., Crapanzano L., Madonia S., Cannizzaro M., Bruno E.M., Licata A., Amodeo S., Capitano A.R., Ferrari C., Negri E., Orlandini A., Pesci M., Gulminetti R., Pagnucco L., Parruti G., Stefano P.D., Coco B., Corsini R., Garlassi E., Andreoni M., Teti E., Cerva C., Baiocchi L., Grassi G., Gasbarrini A., Pompili M., Siena M.D., Taliani G., Spaziante M., Persico M., Masarone M., Aglitti A., Calvanese G., Anselmo M., Leo P.D., Marturano M., Saracco G.M., Quaranta, M, Ferrigno, L, Tata, X, D'Angelo, F, Massari, M, Coppola, C, Biliotti, E, Giorgini, A, Laccabue, D, Ciancio, A, Blanc, P, Margotti, M, Ieluzzi, D, Brunetto, M, Barbaro, F, Russo, F, Beretta, I, Morsica, G, Verucchi, G, Saracino, A, Galli, M, Kondili, L, Mazzaro, C, Bertola, M, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Fiorentini, A, Angarano, G, Milella, M, Leo, A, Rendina, M, Salvatore D'ABRAMO, F, Lillo, C, Iannone, A, Piazzolla, M, Badia, L, Piscaglia, F, Benevento, F, Serio, I, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Bruno, R, Mondelli, M, Chessa, L, Loi, M, Torti, C, Costa, C, Mazzitelli, M, Pisani, V, Scaglione, V, Trecarichi, E, Zignego, A, Monti, M, Madia, F, Attala, L, Pierotti, P, Salomoni, E, Mariabelli, E, Santantonio, T, Bruno, S, Cela, E, Bassetti, M, Mazzarello, G, Alessandrini, A, Biagio, A, Nicolini, L, Raimondo, G, Filomia, R, Aghemo, A, Meli, R, Lazzarin, A, Salpietro, S, Fracanzani, A, Fatta, E, Lombardi, R, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Puoti, M, Baiguera, C, D'Amico, F, Vinci, M, Rumi, M, Zuin, M, Zermiani, P, Andreone, P, Caraceni, P, Guarneri, V, Villa, E, Bernabucci, V, Bristot, L, Paradiso, M, Migliorino, G, Gambaro, A, Lapadula, G, Spolti, A, Soria, A, Invernizzi, P, Ciaccio, A, Luca, M, Malinverno, F, Ratti, L, Amoruso, D, Pisano, F, Scarano, F, Staiano, L, Morisco, F, Cossiga, V, Gentile, I, Buonomo, A, Foggia, M, Zappulo, E, Federico, A, Dallio, M, Coppola, N, Sagnelli, C, Martini, S, Monari, C, Nardone, G, Sgamato, C, Chemello, L, Cavalletto, L, Sterrantino, D, Zanetto, A, Zanaga, P, Brancaccio, G, Craxi, A, Petta, S, Calvaruso, V, Crapanzano, L, Madonia, S, Cannizzaro, M, Bruno, E, Licata, A, Amodeo, S, Capitano, A, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Gulminetti, R, Pagnucco, L, Parruti, G, Stefano, P, Coco, B, Corsini, R, Garlassi, E, Andreoni, M, Teti, E, Cerva, C, Baiocchi, L, Grassi, G, Gasbarrini, A, Pompili, M, Siena, M, Taliani, G, Spaziante, M, Persico, M, Masarone, M, Aglitti, A, Calvanese, G, Anselmo, M, Leo, P, Marturano, M, Saracco, G, Quaranta, M. G., Ferrigno, L., Tata, X., D'Angelo, F., Massari, M., Coppola, C., Biliotti, E., Giorgini, A., Laccabue, D., Ciancio, A., Blanc, P. L., Margotti, M., Ieluzzi, D., Brunetto, M. R., Barbaro, F., Russo, F. P., Beretta, I., Morsica, G., Verucchi, G., Saracino, A., Galli, M., Kondili, L. A., Mazzaro, C., Bertola, M., Benedetti, A., Schiada, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Fiorentini, A., Angarano, G., Milella, M., Leo, A. D., Rendina, M., Salvatore D'ABRAMO, F., Lillo, C., Iannone, A., Piazzolla, M., Badia, L., Piscaglia, F., Benevento, F., Serio, I., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Bruno, R., Mondelli, M., Chessa, L., Loi, M., Torti, C., Costa, C., Mazzitelli, M., Pisani, V., Scaglione, V., Trecarichi, E. M., Zignego, A. L., Monti, M., Madia, F., Attala, L., Pierotti, P., Salomoni, E., Mariabelli, E., Santantonio, T. A., Bruno, S. R., Cela, E. M., Bassetti, M., Mazzarello, G., Alessandrini, A. I., Biagio, A. D., Nicolini, L. A., Raimondo, G., Filomia, R., Aghemo, A., Meli, R., Lazzarin, A., Salpietro, S., Fracanzani, A. L., Fatta, E., Lombardi, R., Lampertico, P., Borghi, M., D'Ambrosio, R., Degasperi, E., Puoti, M., Baiguera, C., D'Amico, F., Vinci, M., Rumi, M. G., Zuin, M., Zermiani, P., Andreone, P., Caraceni, P., Guarneri, V., Villa, E., Bernabucci, V., Bristot, L., Paradiso, M. L., Migliorino, G., Gambaro, A., Lapadula, G., Spolti, A., Soria, A., Invernizzi, P., Ciaccio, A., Luca, M., Malinverno, F., Ratti, L., Amoruso, D. C., Pisano, F., Scarano, F., Staiano, L., Morisco, F., Cossiga, V., Gentile, I., Buonomo, A. R., Foggia, M., Zappulo, E., Federico, A., Dallio, M., Coppola, N., Sagnelli, C., Martini, S., Monari, C., Nardone, G., Sgamato, C., Chemello, L., Cavalletto, L., Sterrantino, D., Zanetto, A., Zanaga, P., Brancaccio, G., Craxi, A., Petta, S., Calvaruso, V., Crapanzano, L., Madonia, S., Cannizzaro, M., Bruno, E. M., Licata, A., Amodeo, S., Capitano, A. R., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Gulminetti, R., Pagnucco, L., Parruti, G., Stefano, P. D., Coco, B., Corsini, R., Garlassi, E., Andreoni, M., Teti, E., Cerva, C., Baiocchi, L., Grassi, G., Gasbarrini, A., Pompili, M., Siena, M. D., Taliani, G., Spaziante, M., Persico, M., Masarone, M., Aglitti, A., Calvanese, G., Anselmo, M., Leo, P. D., Marturano, M., and Saracco, G. M.

Subjects
Male, HCV genotypes, Ethnic group, Linked-to-care patient, Comorbidity, Hepacivirus, Logistic regression, medicine.disease_cause, Comorbidities, Direct acting antivirals, HCV Cohort, Linked-to-care patients, Aged, Antiviral Agents, Coinfection, Female, Hepatitis C, Chronic, Humans, Italy, Middle Aged, Transients and Migrants, 0302 clinical medicine, Medicine, Chronic, Gastroenterology, virus diseases, Hepatitis C, Life evaluation, 030220 oncology & carcinogenesis, Cohort, 030211 gastroenterology & hepatology, Comorbiditie, Human, Hepatitis C virus, Settore MED/12 - GASTROENTEROLOGIA, 03 medical and health sciences, Disease severity, Antiviral Agent, Hepaciviru, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, digestive system diseases, Direct acting antiviral, business, Demography
Abstract

Background: Direct-acting antivirals are highly effective for the treatment of hepatitis C virus (HCV) infection, regardless race/ethnicity. We aimed to evaluate demographic, virological and clinical data of HCV-infected migrants vs. natives consecutively enrolled in the PITER cohort. Methods: Migrants were defined by country of birth and nationality that was different from Italy. Mann-Whitney U test, Chi-squared test and multiple logistic regression were used. Results: Of 10,669 enrolled patients, 301 (2.8%) were migrants: median age 47 vs. 62 years, (p < 0.001), females 56.5% vs. 45.3%, (p < 0.001), HBsAg positivity 3.8% vs. 1.4%, (p < 0.05). Genotype 1b was prevalent in both groups, whereas genotype 4 was more prevalent in migrants (p < 0.05). Liver disease severity and sustained virologic response (SVR) were similar. A higher prevalence of comorbidities was reported for natives compared to migrants (p < 0.05). Liver disease progression cofactors (HBsAg, HIV coinfection, alcohol abuse, potential metabolic syndrome) were present in 39.1% and 47.1% (p > 0.05) of migrants and natives who eradicated HCV, respectively. Conclusion: Compared to natives, HCV-infected migrants in care have different demographics, HCV genotypes, viral coinfections and comorbidities and similar disease severity, SVR and cofactors for disease progression after HCV eradication. A periodic clinical assessment after HCV eradication in Italians and migrants with cofactors for disease progression is warranted.

Published
2021

12. Comparison of three therapeutic regimens for genotype-3 hepatitis C virus infection in a large real-life multicentre cohort

Author

Sergio Lazzaroni, Paolo Grossi, Chiara Molteni, Maria Grazia Valsecchi, Pietro Lampertico, Luca Valenti, Alessio Aghemo, Alessia Giorgini, Antonella d'Arminio Monforte, Roberta D'Ambrosio, Federico Gatti, Omar Giglio, Daniele Bella, Davide Paolo Bernasconi, Giuseppe Lapadula, Sherrie Bhoori, Hamid Hasson, Monica Schiavini, Elisa Colella, Roberto Boldizzoni, A. Ciaccio, Simona Landonio, Andrea Capretti, Maria Cristina Vinci, Giuliano Rizzardini, Barbara Menzaghi, Elisabetta Degasperi, Caterina Uberti-Foppa, Chiara Baiguera, Andrea Lombardi, Gianpiero Aimo, Layla Pagnucco, Paolo Perini, Giuliana Cologni, Natalia Terreni, Paolo Bonfanti, Mauro Viganò, Paolo Viganò, Alessandro Soria, Roberto Rossotti, Massimo Puoti, Ombretta Spinelli, Canio Carriero, Silvia Polo, Guglielmo Marco Migliorino, Silvia Colombo, Riccardo Centenaro, Luisa Pasulo, Anna De Bona, E. Dionigi, Paolo Poggio, Franco Noventa, Isabella Carderi, Angelo Pan, Angiola Spinetti, Mariella Di Marco, Cecilia Liani, Stefano Fagiuoli, Marie Graciella Pigozzi, Marco Fava, Massimo Graffeo, Maria Grazia Rumi, Alberto Colombo, Soria, A., Fava, M., Bernasconi, D. P., Lapadula, G., Colella, E., Valsecchi, M. G., Migliorino, G. M., D'Ambrosio, R., Landonio, S., Schiavini, M., Spinetti, A., Carriero, C., Degasperi, E., Cologni, G., Gatti, F., Vigano, P., Hasson, H., Uberti-Foppa, C., Pasulo, L., Baiguera, C., Rossotti, R., Vinci, M., Puoti, M., Giorgini, A., Menzaghi, B., Lombardi, A., Pan, A., Aghemo, A., Grossi, P. A., Boldizzoni, R., Colombo, S., Vigano, M., Rumi, M. G., Del Poggio, P., Valenti, L., Giglio, O., De Bona, A., d'Arminio Monforte, A., Colombo, A., Spinelli, O., Pigozzi, M. G., Molteni, C., Bonfanti, P., Terreni, N., Perini, P., Capretti, A., Bella, D., Liani, C., Polo, S., Aimo, G., Pagnucco, L., Bhoori, S., Centenaro, R., Graffeo, M., Ciaccio, A., Dionigi, E., Lazzaroni, S., Carderi, I., Di Marco, M., Rizzardini, G., Noventa, F., Lampertico, P., Fagiuoli, S., Soria, A, Fava, M, Bernasconi, D, Lapadula, G, Colella, E, Valsecchi, M, Migliorino, G, D'Ambrosio, R, Landonio, S, Schiavini, M, Spinetti, A, Carriero, C, Degasperi, E, Cologni, G, Gatti, F, Vigano, P, Hasson, H, Uberti-Foppa, C, Pasulo, L, Baiguera, C, Rossotti, R, Vinci, M, Puoti, M, Giorgini, A, Menzaghi, B, Lombardi, A, Pan, A, Aghemo, A, Grossi, P, Boldizzoni, R, Colombo, S, Vigano, M, Rumi, M, Del Poggio, P, Valenti, L, Giglio, O, De Bona, A, d'Arminio Monforte, A, Colombo, A, Spinelli, O, Pigozzi, M, Molteni, C, Bonfanti, P, Terreni, N, Perini, P, Capretti, A, Bella, D, Liani, C, Polo, S, Aimo, G, Pagnucco, L, Bhoori, S, Centenaro, R, Graffeo, M, Ciaccio, A, Dionigi, E, Lazzaroni, S, Carderi, I, Di Marco, M, Rizzardini, G, Noventa, F, Lampertico, P, and Fagiuoli, S

Subjects
Male, medicine.medical_specialty, Daclatasvir, Genotype, Sofosbuvir, ribavirin, pibrentasvir, daclatasvir, genotype 3, glecaprevir, Hepatitis C, sofosbuvir, sustained virological response, velpatasvir, Hepacivirus, Antiviral Agents, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Ribavirin, medicine, Humans, Univariate analysis, Hepatology, business.industry, Glecaprevir, Hepatitis C, Chronic, medicine.disease, Pibrentasvir, Regimen, Treatment Outcome, chemistry, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

Background & Aims: In the direct-acting antiviral era, treatment of genotype-3 HCV (HCV-GT3) is still challenging. Real-life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir (DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap. Methods: Sustained virological response 12weeks after treatment completion (SVR12) was assessed for all HCV-GT3 patients consecutively treated within the Lombardia web-based Navigatore HCV-Network; differences in SVR12 across regimens were evaluated by logistic regression. Results: Of the 2082 subjects with HCV-GT3, 1544 were evaluable for comparisons between regimens: SOF+DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV-positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV-RNA. SVR12 was similar across groups: 94.8% in SOF+DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P=.065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P=.007) and lower median pretreatment Log10HCV-RNA (5.87 vs 6.20, P=.001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF+DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV-RNA were independently associated with SVR12. Conclusions: In a large real-life setting of HCV-GT3-infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF+DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier-to-treat patients allows ribavirin-free and shorter schedules without mining SVR12 in this <> genotype.

Published
2020

13. Liver alterations in anorexia nervosa are not caused by insulin resistance

Author

A. Benetti, Antonio E. Pontiroli, Alice Fanin, Emanuela Bertolini, Lucia Miele, and Alessia Giorgini

Subjects
medicine.medical_specialty, Anorexia Nervosa, 030204 cardiovascular system & hematology, Gastroenterology, Pathogenesis, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Insulin resistance, Internal medicine, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Ultrasonography, Anthropometry, medicine.diagnostic_test, business.industry, Fatty liver, Alanine Transaminase, Magnetic resonance imaging, medicine.disease, Fatty Liver, Liver, Anorexia nervosa (differential diagnoses), Emergency Medicine, Homeostatic model assessment, Insulin Resistance, Transient elastography, business
Abstract

Liver dysfunction has been widely reported in connection with anorexia nervosa (AN) but the pathogenesis of these alterations has never been fully understood despite reported theories about the presence of insulin resistance (IR) and non-alcoholic fatty liver disease (NAFLD). The aim of this study is to investigate if hypertransaminasemia in AN is linked to IR and NAFLD. Anthropometric data and laboratory exams of 34 patients and 34 controls were analyzed, including alanine-aminotransferase, aspartate-aminotransferase and homeostatic model assessment of insulin resistance (HOMA-IR) index. All subjects also underwent magnetic resonance imaging (MRI), ultrasonography (US), and transient elastography (TE). Evidence of increased alanine aminotransferase in AN patients was confirmed in our sample together with a lower HOMA-IR index compared to controls. Positive results in US appeared in 16 patients vs none in controls (p = 0.0007); patients with liver parenchyma abnormalities in US were not different than normal-US patients in any of the studied variables. Only one patient showed non-alcoholic fatty liver disease in MRI while abnormal TE was found in four patients and never in controls. Liver damage suggested by increased serum liver enzymes cannot be due to liver steatosis but potentially to a different liver disease (not identified by MRI) or to an early liver fibrosis not associated with an insulin-resistant status.

Published
2019

14. VIRONET-C real life experience of resistance-guided retreatment in HCV infected patients who previously failed a NS5A inhibitor-containing regimen

Author

Mario Starace, Valerio Giannelli, Nunzia Cuomo, Vanni Borghi, Aldo Bertoli, Anna Licata, Anna Claudia Pellicelli, C. Minichini, M. Andreoni, M. Di Stefano, Giuseppe Cariti, Enzo Boeri, Raffaele Cozzolongo, Roberto Gulminetti, E. Milano, Valeria Cento, Elisabetta Degasperi, Laura Sighinolfi, A. Raddi, Ivana Maida, Barbara Rossetti, Teresa Santantonio, Valeria Micheli, C. Masetti, P. Andreone, Giustino Parruti, F. Di Lorenzo, Ilaria Lenci, Tiziano Allice, Annapaola Callegaro, Elisa Biliotti, M. Lichtner, Teresa Pollicino, Pietro Lampertico, Gloria Taliani, Caterina Pasquazzi, Piero Colombatto, Alessia Giorgini, G. Raimondo, Antonio Craxì, Francesca Ceccherini-Silberstein, Filomena Morisco, Valeria Ghisetti, V.C. Di Maio, Giuliano Rizzardini, Silvia Galli, Stefania Paolucci, A. De Santis, A. Lleo, Vincenzo Sangiovanni, A. Ciancio, Maurizio Zazzi, Elisabetta Teti, Simona Marenco, William Gennari, Stefano Novati, Giovanni Cenderello, Simona Landonio, Manuela Merli, A. Scuteri, Nicola Coppola, C.F. Perno, Giulia Morsica, I. Beretta, Claudio Maria Mastroianni, Simona Francioso, Mario Angelico, Laura Ambra Nicolini, Chiara Dentone, Silvia Barbaliscia, G.B. Gaeta, Marianna Aragri, Ennio Polilli, L. Donnarumma, Vincenza Calvaruso, Bianca Bruzzone, Fausto Baldanti, V. Pace Palitti, Roberto Ganga, Maurizia Rossana Brunetto, C. Paternoster, Sergio Babudieri, M. Puoti, Hamid Hasson, and M. Rendina

Subjects
medicine.medical_specialty, Regimen, Hepatology, business.industry, Internal medicine, Gastroenterology, medicine, business, NS5A
Published
2020

15. Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure

Author

Elisabetta, Degasperi, Angiola, Spinetti, Andrea, Lombardi, Simona, Landonio, Maria Cristina, Rossi, Luisa, Pasulo, Pietro, Pozzoni, Alessia, Giorgini, Paolo, Fabris, Antonietta, Romano, Lorenzo, Lomonaco, Massimo, Puoti, Maria, Vinci, Federico, Gatti, Giada, Carolo, Alessia, Zoncada, Paolo, Bonfanti, Russo, FRANCESCO PAOLO, Alessio, Aghemo, Alessandro, Soria, Riccardo, Centenaro, Franco, Maggiolo, Pierangelo, Rovere, Francesca, Pasin, Veronica, Paon, Giovanni, Faggiano, Alessandro, Vario, Glenda, Grossi, Roberta, Soffredini, Canio, Carriero, Stefania, Paolucci, Franco, Noventa, Alfredo, Alberti, Pietro, Lampertico, Stefano, Fagiuoli, NAVIGATORE-Lombardia and Veneto Study Groups, Degasperi, E, Spinetti, A, Lombardi, A, Landonio, S, Rossi, M, Pasulo, L, Pozzoni, P, Giorgini, A, Fabris, P, Romano, A, Lomonaco, L, Puoti, M, Vinci, M, Gatti, F, Carolo, G, Zoncada, A, Bonfanti, P, Russo, F, Aghemo, A, Soria, A, Centenaro, R, Maggiolo, F, Rovere, P, Pasin, F, Paon, V, Faggiano, G, Vario, A, Grossi, G, Soffredini, R, Carriero, C, Paolucci, S, Noventa, F, Alberti, A, Lampertico, P, and Fagiuoli, S

Subjects
0301 basic medicine, Liver Cirrhosis, Male, Sofosbuvir, Sustained Virologic Response, Resistance, Hepacivirus, Viral Nonstructural Proteins, medicine.disease_cause, Direct-acting antiviral, Direct-acting antivirals, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Sulfonamides, Liver Neoplasms, Hepatitis C, Middle Aged, Drug Combinations, Treatment Outcome, Italy, Hepatocellular carcinoma, HCV, RAS, Retreatment, RNA, Viral, 030211 gastroenterology & hepatology, Female, medicine.drug, medicine.medical_specialty, Carcinoma, Hepatocellular, Macrocyclic Compounds, Anemia, Voxilaprevir, Hepatitis C virus, Antiviral Agents, Heterocyclic Compounds, 4 or More Rings, 03 medical and health sciences, Internal medicine, Drug Resistance, Viral, medicine, Humans, Intention-to-treat analysis, Hepatology, business.industry, Ribavirin, Hepatitis C, Chronic, medicine.disease, 030104 developmental biology, chemistry, Carbamates, business
Abstract

Background & Aims Sofosbuvir/velpatasivr/voxilaprevir (SOF/VEL/VOX) is approved for retreatment of patients with HCV and a previous failure on direct-acting antivirals (DAAs), however real-life data are limited. The aim of this study was to assess the effectiveness and safety of SOF/VEL/VOX in a real-life setting. Methods All consecutive patients with HCV receiving SOF/VEL/VOX between May-October 2018 in 27 centers in Northern Italy were enrolled. Bridging fibrosis (F3) and cirrhosis (F4) were diagnosed by liver stiffness measurement: >10 and >13 kPa respectively. Sustained virological response (SVR) was defined as undetectable HCV-RNA 4 (SVR4) or 12 (SVR12) weeks after the end-of-treatment. Results A total of 179 patients were included: median age 57 (18–88) years, 74% males, median HCV-RNA 1,081,817 (482–25,590,000) IU/ml. Fibrosis stage was F0-F2 in 32%, F3 in 21%, F4 in 44%. HCV genotype was 1 in 58% (1b 33%, 1a 24%, 1nc 1%), 2 in 10%, 3 in 23% and 4 in 9%; 82% of patients carried resistance-associated substitutions in the NS3, NS5A or NS5B regions. Patients received SOF/VEL/VOX for 12 weeks, ribavirin was added in 22% of treatment schedules. Undetectable HCV-RNA was achieved by 74% of patients at week 4 and by 99% at week 12. Overall, 162/179 (91%) patients by intention to treat analysis and 162/169 (96%) by per protocol analysis achieved SVR12, respectively; treatment failures included 6 relapsers and 1 virological non-responder. Cirrhosis (p = 0.005) and hepatocellular carcinoma (p = 0.02) were the only predictors of treatment failure. Most frequent adverse events included fatigue (6%), hyperbilirubinemia (6%) and anemia (4%). Conclusions SOF/VEL/VOX is an effective and safe retreatment for patients with HCV who have failed on a previous DAA course in a real-life setting. Lay summary This is the largest European real-life study evaluating effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in a large cohort of consecutive patients with hepatitis C virus infection and a prior direct-acting antiviral failure, who were treated within the NAVIGATORE Lombardia and Veneto Networks, in Italy. This study demonstrated excellent effectiveness (98% and 96% sustained virological response rates at week 4 and 12, respectively) and an optimal safety profile of SOF/VEL/VOX. Cirrhosis and hepatocellular carcinoma onset were the only features associated with treatment failure.

Published
2019

16. Predictors of hepatocellular carcinoma in HCV cirrhotic patients treated with direct acting antivirals

Author

Maurizia Rossana Brunetto, Pietro Andreone, Massimo Colombo, Vincenza Calvaruso, Savino Bruno, L. Marzi, Patrick Maisonneuve, Alfredo Di Leo, Massimo Zuin, Ana Lleo, Giulia Troshina, Alessia Giorgini, Fabio Conti, Simona Bollani, Vito Di Marco, Andrea Aglitti, Maria Rendina, V. Boccaccio, Pietro Lampertico, Alessio Aghemo, Alessia Ciancio, Barbara Coco, Erica Villa, Marcello Persico, Elisabetta Degasperi, Lleo A1, Aglitti A2, Aghemo A1, Maisonneuve P3, Bruno S1, Persico M4, Rendina M5, Ciancio A6, Lampertico P7, Brunetto MR8, Di Marco Vito, Zuin M10, Andreone P11, Villa E12, Troshina G6, Degasperi E7, Coco B13, Calvaruso Vincenza, Giorgini AM10, Conti F11, Di Leo A5, Marzi L12, Boccaccio V14, Bollani S15, Colombo M16., Lleo, Ana, Aglitti, Andrea, Aghemo, Alessio, Maisonneuve, Patrick, Bruno, Savino, Persico, Marcello, Rendina, Maria, Ciancio, Alessia, Lampertico, Pietro, Brunetto, Maurizia R., Di Marco, Vito, Zuin, Massimo, Andreone, Pietro, Villa, Erica, Troshina, Giulia, Degasperi, Elisabetta, Coco, Barbara, Calvaruso, Vincenza, Giorgini, Alessia M., Conti, Fabio, Di Leo, Alfredo, Marzi, Luca, Boccaccio, Vincenzo, Bollani, Simona, and Colombo, Massimo

Subjects
Liver Cirrhosis, Male, Cirrhosis, Sustained Virologic Response, Hepatocellular carcinoma, Direct antiviral agents, DIRECT ACTING ANTIVIRALS, Gastroenterology, Cohort Studies, 0302 clinical medicine, Risk Factors, Chronic, Incidence (epidemiology), Liver Neoplasms, Middle Aged, Hepatitis C, Tumor recurrence, HCV, Aged, Antiviral Agents, Carcinoma, Hepatocellular, Disease Progression, Female, Hepatitis C, Chronic, Humans, Italy, Neoplasm Recurrence, Local, alpha-Fetoproteins, Local, 030220 oncology & carcinogenesis, Portal hypertension, 030211 gastroenterology & hepatology, Cohort study, medicine.medical_specialty, Early Recurrence, 03 medical and health sciences, Internal medicine, medicine, neoplasms, Cirrhosi, Hepatology, business.industry, Carcinoma, Hepatocellular, medicine.disease, digestive system diseases, Neoplasm Recurrence, Direct antiviral agent, business
Abstract

Background: Despite the dramatic improvement in viral eradication rates that has been reached with direct antiviral agents (DAAs),the real benefit of viral eradication after DAAs on hepatocellular carcinoma (HCC) development is still controversial. Aim: To prospectively assess the risk of HCC occurrence and early recurrence in a large cohort of DAAtreated HCV-cirrhotic patients and to identify potential predictors of HCC development. Methods: We analyzed data prospectively collected from 1927 consecutive HCV-infected cirrhotic patients treated with DAA from January to December 2015 in 10 tertiary liver centers in Italy and followed-up for one year after therapy. 161 patients had a previous HCC. Results: 38/161 subjects developed tumor recurrence during the follow-up (recurrence rate = 24.8 per 100-year), patients with SVR had a significantly lower rate of recurrence. Lack of SVR and alphafetoprotein (AFP) were independent predictors of HCC recurrence. 50/1766 patients without a previous HCC history developed HCC during follow-up (incidence rate = 2.4 per 100-year). Lack of SVR was the strongest predictor of HCC development. Furthermore, patients with SVR and no stigmata of portal hypertension have a lower incidence rate of HCC (1.0 per 100-year). Conclusions: SVR is associated with a significant decrease of recurrent or de novo HCC. Baseline AFP and signs of portal hypertension can help to stratify the risk of HCC. © 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved

Published
2019

17. Seroepidemiology of HEV and HAV in two populations with different socio-economic levels and hygienic/sanitary conditions

Author

Angela Amante, Alfonso Mele, Alessia Giorgini, Fabrizio Marcucci, Massimo Zuin, Pier Maria Battezzati, A.R. Zanetti, Carmelo Antonio Caserta, Catia Tagliacarne, R. Cannatelli, and Luisa Romanò

Subjects
Adult, Male, 0301 basic medicine, Microbiology (medical), Pediatrics, medicine.medical_specialty, Multivariate analysis, Adolescent, viruses, 030106 microbiology, Population, Prevalence, medicine.disease_cause, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Hepatitis E virus, Seroepidemiologic Studies, Epidemiology, medicine, Humans, Seroprevalence, Hepatitis Antibodies, 030212 general & internal medicine, education, Aged, education.field_of_study, business.industry, virus diseases, Hepatitis A, General Medicine, Middle Aged, medicine.disease, Hepatitis E, digestive system diseases, Infectious Diseases, Italy, Socioeconomic Factors, Female, Hepatitis A virus, business, Demography
Abstract

The epidemiological scenarios of hepatitis E virus (HEV) and hepatitis A virus (HAV) infections have changed in the last few decades, but precise epidemiological data on the prevalence of anti-HEV and anti-HAV, alone or in combination, in the general population are scanty. We investigated HEV and HAV seroprevalence comparing two population samples living in Northern (Abbiategrasso, Milan) and Southern Italy (Cittanova, Reggio Calabria), the latter being characterized by a poorer socio-economic level and hygienic/sanitary conditions. Based on census records, we randomly enrolled and tested 3,365 subjects (Abbiategrasso, n = 2,489; Cittanova, n = 876) aged 18-75 years for anti-HAV and anti-HEV. Anti-HAV (71.3 % vs 52.5 %) and anti-HEV (17.8 % vs 9.0 %) prevalence rates were higher in Southern Italy (both p

Published
2016

19. Frequent NS5A and multiclass resistance in almost all HCV genotypes at DAA failures: What are the chances for second-line regimens?

Author

Velia Chiara Di Maio, Valeria Cento, Marianna Aragri, Stefania Paolucci, Teresa Pollicino, Nicola Coppola, Bianca Bruzzone, Valeria Ghisetti, Maurizio Zazzi, Maurizia Brunetto, Ada Bertoli, Silvia Barbaliscia, Silvia Galli, William Gennari, Fausto Baldanti, Giovanni Raimondo, Carlo Federico Perno, Francesca Ceccherini-Silberstein, Pietro Andreone, Massimo Andreoni, Mario Angelico, Sergio Babudieri, Giorgio Barbarini, Vincenzo Boccaccio, Lucio Boglione, Matteo Bolis, Stefano Bonora, Vanni Borghi, Giuseppina Brancaccio, Savino Bruno, Pierluigi Cacciatore, Vincenza Calvaruso, Nicola Caporaso, Antonio Ciaccio, Alessia Ciancio, Piero Colombatto, Raffaele Cozzolongo, Antonio Craxì, Cecilia D'Ambrosio, Gabriella D'Ettorre, Andrea De Luca, Antonio Di Biagio, Giovanni Di Perri, Simona Francioso, Giovanni Battista Gaeta, Alessia Giorgini, Antonio Grieco, Guido Gubertini, Roberto Gulminetti, Lara Lambiase, Ilaria Lenci, Miriam Lichtner, Ivana Maida, Simona Marenco, Letizia Marinaro, Renato Maserati, Chiara Masetti, Michela Melis, Elisa Meregalli, Valeria Micheli, Filomena Morisco, Fosca Niero, Laura Ambra Nicolini, Valeria Pace Palitti, Maurizio Paoloni, Giustino Parruti, Caterina Pasquazzi, Adriano Pellicelli, Ennio Polilli, Maria Laura Ponti, Massimo Puoti, Maria Rendina, Giuliano Rizzardini, Barbara Rossetti, Tina Ruggiero, Vincenzo Sangiovanni, Mario Starace, Laura Sticchi, Pierluigi Tarquini, Pierluigi Toniutto, Vincenzo Vullo, Di Maio VC, Cento V, Aragri M, Paolucci S, Pollicino T3, Coppola N4, Bruzzone B5, Ghisetti V6, Zazzi M7, Brunetto M8, Bertoli A1, Barbaliscia S1, Galli S9, Gennari W10, Baldanti F2, Raimondo G3, Perno CF1, Ceccherini-Silberstein F11, Andreone P, Andreoni M, Angelico M, Babudieri S, Barbarini G, Boccaccio V, Boglione L, Bolis M, Bonora S, Borghi V, Brancaccio G, Bruno S, Cacciatore P, Calvaruso Vincenza, Caporaso N, Ciaccio A, Ciancio A, Colombatto P, Cozzolongo R, Craxì Antonio, D'Ambrosio C, D'Ettorre G, De Luca A, Di Biagio A, Di Perri G, Francioso S, Gaeta GB, Giorgini A, Grieco A, Gubertini G, Gulminetti R, Lambiase L, Lenci I, Lichtner M, Maida I, Marenco S, Marinaro L, Maserati R, Masetti C, Melis M, Meregalli E, Micheli V, Morisco F, Niero F, Nicolini LA, Palitti VP, Paoloni M, Parruti G, Pasquazzi C, Pellicelli A, Polilli E, Ponti ML, Puoti M, Rendina M, Rizzardini G, Rossetti B, Ruggiero T, Sangiovanni V, Starace M, Sticchi L, Tarquini P, Toniutto P, Vullo V., Di Maio, Vc, Cento, V, Aragri, M, Paolucci, S, Pollicino, T, Coppola, N, Bruzzone, B, Ghisetti, V, Zazzi, M, Brunetto, M, Bertoli, A, Barbaliscia, S, Galli, S, Gennari, W, Baldanti, F, Raimondo, G, Perno, Cf, Ceccherini-Silberstein, F., Andreone P, Andreoni, M, Angelico, M, Babudieri, S, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Cacciatore, P, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, Craxì, A, D'Ambrosio, C, D'Ettorre, G, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, Gb, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Lenci, I, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Masetti, C, Melis, M, Meregalli, E, Micheli, V, Morisco, F, Niero, F, Nicolini, La, Palitti, Vp, Paoloni, M, Parruti, G, Pasquazzi, C, Pellicelli, A, Polilli, E, Ponti, Ml, Puoti, M, Rendina, M, Rizzardini, G, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V., Di Maio, V, Perno, C, Ceccherini-Silberstein, F, Andreone, P, Craxi, A, Gaeta, G, Nicolini, L, Palitti, V, Ponti, M, and Vullo, V

Subjects
0301 basic medicine, medicine.medical_specialty, hepacivirus, HCV RAS, Treatment outcome, Drug Resistance, HCV genotypes, Drug resistance, Biology, NS5A, 03 medical and health sciences, 0302 clinical medicine, Second line, drug resistance viral, humans, retreatment, treatment outcome, antiviral agents, hepatitis c chronic, Internal medicine, Drug Resistance, Viral, Humans, Retreatment, Treatment Outcome, Antiviral Agents, Hepacivirus, Hepatitis C, Chronic, medicine, Viral, Chronic, Hepatology, Hepatitis C, Settore MED/07 - Microbiologia e Microbiologia Clinica, medicine.disease, Virology, Hepatology, HCV, NS5A, 030104 developmental biology, HCV, 030211 gastroenterology & hepatology
Published
2018

20. Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

Author

Giada Carolo, Veronica Bernabucci, Luchino Chessa, Maria Luisa Russo, Giorgio Maria Saracco, Marzia Montalbano, Barbara Menzaghi, Giovanni Di Perri, Adriano Lazzarin, Silvia La Monica, Raffaele Bruno, Gian Ludovico Rapaccini, Mario U. Mondelli, Anna Maria Schimizzi, Caterina Pasquazzi, Maurizia Rossana Brunetto, Antonio Craxì, Filomena Morisco, Carmela Lo Guercio, Vania Giacomet, Alessia Giorgini, Mario Masarone, Francesca Paolo Russo, T. Zolfino, Vincenzo Sangiovanni, Alessia Ciancio, Antonella d'Arminio Monforte, Savino Bruno, E.M. Erne, Antonio Gasbarrini, Francesco Castelli, Sergio Novara, G. Nardone, Andrea De Luca, Claudio Maria Mastroianni, Gioacchino Angarano, Chiara Dentone, Renato Maserati, Anna Maria Piscaglia, Tiziana Quirino, Giuseppe Tarantino, M. Lichtner, Antonio Chirianni, Giuseppina Brancaccio, S. Paganin, Alfredo Alberti, Silvia Corradori, Edoardo G. Giannini, Carlo Torti, Chiara Boarini, Raffaele Cozzolongo, Marco Di Stefano, Alessandro Soria, Paolo Tundi, Giovanni Cassola, Debora Angrisani, Antonio Grieco, Cecilia Pravadelli, Giuliano Rizzardini, Roberto Gulminetti, Vincenzo Messina, Maria Rendina, Massimo Pirisi, Irene Cacciola, Roberto Ganga, Raffaella Lionetti, Paolo Calabrese, Laura Ponti, Filomena Simeone, Maurizio Russello, Monica Monti, Nicola Boffa, Pierluigi Tarquini, Franco Capra, Ivo Avancini, Domenico Sansonno, Stefano Fagiuoli, Michele Barone, Giacomo Vecchiet, Salvatore Rizzo, Carlo Federico Perno, Teresa Santantonio, Pierluigi Toniutto, Massimo Zuin, Nicola Caporaso, Alessandra Orlandini, Grazielle Marie Pigozzi, Martina Felder, Antonio Cristaudo, Roberto Cecere, Massimo Marignani, Vincenza Calvaruso, G. Abbati, Domenico Potenza, Maria Chiara Piras, Mario Rizzetto, Serena Cima, Marco delle Monache, Alessio Aghemo, D. Ieluzzi, Guglielmo Borgia, Giampaolo Corti, Paolo Poggio, Manuela Merli, Elena Danieli, Andrea Giacometti, Massimo Andreoni, Antonino Picciotto, Mario Angelico, Benedetta Canovari, Sara Piovesan, Anna Linda Zignego, Antonio Benedetti, Emanuele Durante, Erica Villa, Marcello Persico, Antonio Patrizio Termite, Barbara Coco, Maria Vinci, Lucio Boglione, Cristina Rossi, Paolo Angeli, Massimo Memoli, Maria Teresa Giordani, Massimo De Luca, Luisa Pasulo, Vincenzo Vullo, Mario Melazzini, Attilio Solinas, Pietro Gatti, Michele Guerra, Silvia Martini, Antonio Ascione, Massimo Puoti, Roberto Cauda, Giovanna Onnelli, Silvia Magnani, Salvatore Madonna, Giovanni Raimondo, Marco Tabone, Gloria Taliani, Dante Romagnoli, Aldo Marrone, Umberto Vespasiani Gentilucci, Luca Miele, Marcello Tavio, Andrea Antinori, Giampiero D'Offizi, Mirella Onofrio, Valentina Iodice, Lucio Cosco, Guido Piai, Luca Pani, Francesca Ceccherini Silberstein, Simona Montilla, Marco Lenzi, Luca Fontanella, Alessandro Federico, Carlo Ferrari, Giustino Parruti, Antonio Di Biagio, Gabriella Verucchi, Fabio Marsetti, Michele Milella, Maria Grazia Rumi, Antonio Izzi, Marco Marzioni, Francesca Donato, Vanni Borghi, Mariano Quartini, Massimo Colombo, Michele Imparato, Giovanni Battista Gaeta, P.L. Blanc, Alfredo Di Leo, Nicola Coppola, Alessandro Chiodera, Ivana Maida, Davide Campagnolo, Cinzia Antonini, Antonietta Romano, A. Gianstefani, Katia Falasca, Massimo Levrero, Gaetano Serviddio, Maria Paola Trotta, Olivia Morelli, Salvatore Petta, Elisabetta Teti, Maria Rita Parisi, Pietro Andreone, Ascione, Antonio, De Luca, Massimo, Melazzini, Mario, Montilla, Simona, Trotta, Maria Paola, Petta, Salvatore, Puoti, Massimo, Sangiovanni, Vincenzo, Messina, Vincenzo, Bruno, Savino, Izzi, Antonio, Villa, Erica, Aghemo, Alessio, Zignego, Anna Linda, Orlandini, Alessandra, Fontanella, Luca, Gasbarrini, Antonio, Marzioni, Marco, Giannini, Edoardo G., Craxì, Antonio, Abbati, Giuseppe, Alberti, Alfredo, Andreone, Pietro, Andreoni, Massimo, Angeli, Paolo, Angelico, Mario, Angarano, Gioacchino, Angrisani, Debora, Antinori, Andrea, Antonini, Cinzia, Avancini, Ivo, Barone, Michele, Bruno, Raffaele, Benedetti, Antonio, Bernabucci, Veronica, Blanc, Pier, Boarini, Chiara, Boffa, Nicola, Boglione, Lucio, Borghi, Vanni, Borgia, Guglielmo, Brancaccio, Giuseppina, Brunetto, Maurizia, Cacciola, Irene, Calabrese, Paolo, Calvaruso, Vincenza, Campagnolo, Davide, Canovari, Benedetta, Caporaso, Nicola, Capra, Franco, Carolo, Giada, Cassola, Giovanni, Castelli, Francesco, Cauda, Roberto, Silberstein, Francesca Ceccherini, Cecere, Roberto, Chessa, Luchino, Chiodera, Alessandro, Chirianni, Antonio, Ciancio, Alessia, Cima, Serena, Coco, Barbara, Colombo, Massimo, Coppola, Nicola, Corti, Giampaolo, Cosco, Lucio, Corradori, Silvia, Cozzolongo, Raffaele, Cristaudo, Antonio, Danieli, Elena, Monforte, Antonella D’Arminio, Monache, Marco delle, Del Poggio, Paolo, de Luca, Andrea, Dentone, Chiara, Di Biagio, Antonio, Di Leo, Alfredo, Di Perri, Giovanni, Di Stefano, Marco, D’Offizi, Giampiero, Donato, Francesca, Durante, Emanuele, Erne, Elke, Fagiuoli, Stefano, Falasca, Katia, Federico, Alessandro, Felder, Martina, Ferrari, Carlo, Gaeta, Giovanni Battista, Ganga, Roberto, Gatti, Pietro, Giacomet, Vania, Giacometti, Andrea, Gianstefani, Alice, Giordani, Maria, Giorgini, Alessia, Grieco, Antonio, Guerra, Michele, Gulminetti, Roberto, Ieluzzi, Donatella, Imparato, Michele, Iodice, Valentina, La Monica, Silvia, Lazzarin, Adriano, Lenzi, Marco, Levrero, Massimo, Lichtner, Myriam, Lionetti, Raffaella, Guercio, Carmela Lo, Madonna, Salvatore, Magnani, Silvia, Maida, Ivana, Marignani, Massimo, Marrone, Aldo, Marsetti, Fabio, Martini, Silvia, Masarone, Mario, Maserati, Renato, Mastroianni, Claudio Maria, Memoli, Massimo, Menzaghi, Barbara, Merli, Manuela, Miele, Luca, Milella, Michele, Mondelli, Mario, Montalbano, Marzia, Monti, Monica, Morelli, Olivia, Morisco, Filomena, Nardone, Gaetano, Novara, Sergio, Onnelli, Giovanna, Onofrio, Mirella, Paganin, Simona, Pani, Luca, Parisi, Maria Rita, Parruti, Giustino, Pasquazzi, Caterina, Pasulo, Luisa, Perno, Carlo Federico, Persico, Marcello, Piai, Guido, Picciotto, Antonino, Pigozzi, Grazielle Marie, Piovesan, Sara, Piras, Maria Chiara, Pirisi, Massimo, Piscaglia, Anna Maria, Ponti, Laura, Potenza, Domenico, Pravadelli, Cecilia, Quartini, Mariano, Quirino, Tiziana, Raimondo, Giovanni, Rapaccini, Gian Ludovico, Rendina, Maria, Rizzardini, Giuliano, Rizzetto, Mario, Rizzo, Salvatore, Romagnoli, Dante, Romano, Antonietta, Rossi, Cristina, Rumi, Maria Grazia, Russello, Maurizio, Russo, Francesca Paolo, Russo, Maria Luisa, Sansonno, Domenico Ettore, Santantonio, Teresa Antonia, Saracco, Giorgio, Schimizzi, Anna Maria, Serviddio, Gaetano, Simeone, Filomena, Solinas, Attilio, Soria, Alessandro, Tabone, Marco, Taliani, Gloria, Tarantino, Giuseppe, Tarquini, Pierluigi, Tavio, Marcello, Termite, Antonio, Teti, Elisabetta, Toniutto, Pierluigi, Torti, Carlo, Tundi, Paolo, Vecchiet, Giacomo, Verucchi, Gabriella, Gentilucci, Umberto Vespasiani, Vinci, Maria, Vullo, Vincenzo, Zolfino, Teresa, Zuin, Massimo, Ascione, A, De Luca, M, Melazzini, M, Montilla, S, Trotta, M, Petta, S, Puoti, M, Sangiovanni, V, Messina, V, Bruno, S, Izzi, A, Villa, E, Aghemo, A, Zignego, A, Orlandini, A, Fontanella, L, Gasbarrini, A, Marzioni, M, Giannini, E, Craxi, A, Abbati, G, Alberti, A, Andreone, P, Andreoni, M, Angeli, P, Angelico, M, Angarano, G, Angrisani, D, Antinori, A, Antonini, C, Avancini, I, Barone, M, Bruno, R, Benedetti, A, Bernabucci, V, Blanc, P, Boarini, C, Boffa, N, Boglione, L, Borghi, V, Borgia, G, Brancaccio, G, Brunetto, M, Cacciola, I, Calabrese, P, Calvaruso, V, Campagnolo, D, Canovari, B, Caporaso, N, Capra, F, Carolo, G, Cassola, G, Castelli, F, Cauda, R, Silberstein, F, Cecere, R, Chessa, L, Chiodera, A, Chirianni, A, Ciancio, A, Cima, S, Coco, B, Colombo, M, Coppola, N, Corti, G, Cosco, L, Corradori, S, Cozzolongo, R, Cristaudo, A, Danieli, E, Monforte, A, Monache, M, Del Poggio, P, de Luca, A, Dentone, C, Di Biagio, A, Di Leo, A, Di Perri, G, Di Stefano, M, D'Offizi, G, Donato, F, Durante, E, Erne, E, Fagiuoli, S, Falasca, K, Federico, A, Felder, M, Ferrari, C, Gaeta, G, Ganga, R, Gatti, P, Giacomet, V, Giacometti, A, Gianstefani, A, Giordani, M, Giorgini, A, Grieco, A, Guerra, M, Gulminetti, R, Ieluzzi, D, Imparato, M, Iodice, V, La Monica, S, Lazzarin, A, Lenzi, M, Levrero, M, Lichtner, M, Lionetti, R, Guercio, C, Madonna, S, Magnani, S, Maida, I, Marignani, M, Marrone, A, Marsetti, F, Martini, S, Masarone, M, Maserati, R, Mastroianni, C, Memoli, M, Menzaghi, B, Merli, M, Miele, L, Milella, M, Mondelli, M, Montalbano, M, Monti, M, Morelli, O, Morisco, F, Nardone, G, Novara, S, Onnelli, G, Onofrio, M, Paganin, S, Pani, L, Parisi, M, Parruti, G, Pasquazzi, C, Pasulo, L, Perno, C, Persico, M, Piai, G, Picciotto, A, Pigozzi, G, Piovesan, S, Piras, M, Pirisi, M, Piscaglia, A, Ponti, L, Potenza, D, Pravadelli, C, Quartini, M, Quirino, T, Raimondo, G, Rapaccini, G, Rendina, M, Rizzardini, G, Rizzetto, M, Rizzo, S, Romagnoli, D, Romano, A, Rossi, C, Rumi, M, Russello, M, Russo, F, Russo, M, Sansonno, D, Santantonio, T, Saracco, G, Schimizzi, A, Serviddio, G, Simeone, F, Solinas, A, Soria, A, Tabone, M, Taliani, G, Tarantino, G, Tarquini, P, Tavio, M, Termite, A, Teti, E, Toniutto, P, Torti, C, Tundi, P, Vecchiet, G, Verucchi, G, Gentilucci, U, Vinci, M, Vullo, V, Zolfino, T, and Zuin, M

Subjects
Cyclopropanes, Liver Cirrhosis, Male, Cirrhosis, Dasabuvir, Elderly, Ombitasvir, Paritaprevir, Aged, 80 and over, Anilides, Antiviral Agents, Biomarkers, Carbamates, Female, Hepacivirus, Hepatitis C, Chronic, Humans, Macrocyclic Compounds, Ribavirin, Ritonavir, Sulfonamides, Treatment Outcome, Uracil, Drug Therapy, Combination, Genotype, Cirrhosis, Dasabuvir, Elderly, Ombitasvir, Paritaprevir, Microbiology (medical), Infectious Diseases, Aged, 80 and over, Hepatitis C, Chronic, Drug Therapy, Combination, Microbiology (medical), Infectious Diseases, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, 2-Naphthylamine, Medicine, 030212 general & internal medicine, Valine, General Medicine, 030211 gastroenterology & hepatology, Macrocyclic Compound, medicine.drug, Human, medicine.medical_specialty, Proline, Lactams, Macrocyclic, Settore MED/12 - GASTROENTEROLOGIA, Liver Cirrhosi, Sulfonamide, 03 medical and health sciences, Internal medicine, Decompensation, Hepatitis, Antiviral Agent, Cirrhosi, Hepaciviru, business.industry, Settore MED/09 - MEDICINA INTERNA, Anilide, Biomarker, medicine.disease, chemistry, Carbamate, business
Abstract

Purpose: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65years. Methods: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100mg) and twice-daily dasabuvir (250mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks. Endpoints were to evaluate safety and efficacy, the latter defined as HCV RNA negative 12weeks after the end of treatment (SVR12). Results: Patients who suffered any adverse event (AE) were 74/240 (30.8%); 13/240 (5.4%) discontinued the treatment. A multivariate analysis found albumin < 3.5g/dL (OR 2.04: 95% CI 1.0–4.2, p < 0.05) and hypertension (OR 4.6: 95% CI 2.3–9.2, p < 0.001) as variables independently associated with AE occurrence. The SVR12 was 95% (228/240). Multivariate analysis identified baseline bilirubin < 2mg/dL (OR 4.9: 95% CI 1.17–20.71, p = 0.029) as the only variable independently associated with SVR12. Conclusion: Our findings suggest that OBV/PTV/r + DSV + RBV is safe and effective in real-life use in patients with compensated cirrhosis, HCV-GT1 infection, and age over 65.

Published
2018

21. THU-141-Efficacy and safety of elbasvir/grazoprevir in a large real-life cohort of HCV-infected patients

Author

Alberto Colombo, Sandro Panese, Mauro Viganò, Simona Landonio, Agostino Colli, Barbara Menzaghi, Caterina Uberti-Foppa, Veronica Paon, Paolo Sacchi, Maria Cristina Rossi, Francesca Cattelan, Andrea Capretti, Maria Cristina Vinci, Luisa Pasulo, Valter Vincenzi, S. Lobello, Giada Carolo, Liliana Chemello, Ombretta Spinelli, Roberta D'Ambrosio, Monia Mendeni, Franco Capra, Alessandro Soria, Roberta Soffredini, Maurizio Carrara, M. Colpani, Massimo Puoti, Giancarlo Spinzi, Alfredo Alberti, Pietro Lampertico, Luisa Cavalletto, Angiola Spinetti, Elisabetta Degasperi, Massimo Zuin, Alessio Aghemo, Laura Comi, Giovanna Cardaci, Valentina Zuccaro, Massimo Memoli, Paolo Poggio, Angelo Pan, Vinicio Manfrin, Alessia Giorgini, Marie Graciella Pigozzi, Serena Zaltron, Francesco Castelli, Franco Noventa, Paolo Grossi, Monica Schiavini, Clara Dibenedetto, Antonella d'Arminio Monforte, Roberto Gulminetti, Elisabetta Buscarini, Piergiorgio Scotton, Stefano Fagiuoli, Martina Gambato, Francesco Russo, Andrea Gori, Paolo Fabris, Caterina Pozzan, and Maria Grazia Rumi

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Cohort, medicine, Elbasvir, Grazoprevir, business
Published
2019

22. THU-166-Treatment of 320 genotype 3 cirrhotic patients with 12 weeks of sofosbuvir/velpatasvir with or without ribavirin: Real life experience from Italy

Author

Giancarlo Spinzi, Vito Di Marco, Giada Carolo, Caterina Pozzan, Barbara Menzaghi, Giuliana Cologni, Roberta Soffredini, Mauro Viganò, Colombatto Piero, Carlo Magni, Serena Zaltron, Francesco Castelli, Roberta D'Ambrosio, Monia Mendeni, Alfredo Alberti, Paolo Grossi, Massimo Zuin, Maria Grazia Rumi, Veronica Paon, Luisa Pasulo, Alberto Colombo, Pietro Lampertico, Paolo Sacchi, Monica Schiavini, Alessio Aghemo, Andrea Capretti, Maria Cristina Vinci, Valter Vincenzi, Andrea Lombardi, Alessia Giorgini, Lorenzo Difrancesco, Maria Antonietta Di Rosolini, Piergiorgio Scotton, Francesco Russo, Antonio Albanese, Sandro Panese, Andrea Gori, Franco Noventa, Stefano Fagiuoli, F. Cartabellotta, Agostino Colli, Martina Gambato, Caterina Uberti-Foppa, Angelo Pan, Luisa Cavalletto, Clara Dibenedetto, Antonio Di Giacomo, Franco Capra, Angiola Spinetti, S. Lobello, M. Colpani, Ombretta Spinelli, Vinicio Manfrin, Liliana Chemello, Roberto Gulminetti, Alessandro Soria, Irene Cacciola, Maurizia Rossana Brunetto, Vincenza Calvaruso, Antonella d'Arminio Monforte, Massimo Memoli, Elisabetta Buscarini, Alessia Ciancio, and Massimo Puoti

Subjects
medicine.medical_specialty, chemistry.chemical_compound, Hepatology, chemistry, business.industry, Internal medicine, Ribavirin, Genotype, medicine, business, Gastroenterology, Sofosbuvir/velpatasvir
Published
2019

23. Treatment of 320 genotype 3 cirrhotic patients with 12 weeks Sofosbuvir/Velpatasvir with or without ribavirin: real life experience from Italy

Author

Alessia Ciancio, Angelo Pan, Pietro Lampertico, F. Cartabellotta, Barbara Menzaghi, Alessio Aghemo, S. Lo Bello, Roberta Soffredini, Roberta D'Ambrosio, Monia Mendeni, Roberto Gulminetti, Caterina Pozzan, Piergiorgio Scotton, Mauro Viganò, Sandro Panese, Francesco Russo, Maurizio Carrara, Veronica Paon, Ombretta Spinelli, P. Colombatto, Maurizia Rossana Brunetto, Stefano Fagiuoli, F. Di Lorenzo, Valter Vincenzi, Agostino Colli, Andrea Gori, Martina Gambato, Franco Noventa, Serena Zaltron, Paolo Sacchi, Francesco Castelli, Massimo Zuin, Caterina Uberti-Foppa, Claudio Rossi, Luisa Pasulo, G. Cologni, A. Albanese, V. Di Marco, Andrea Capretti, Maria Cristina Vinci, Giada Carolo, Elisabetta Buscarini, Maria Grazia Rumi, Monica Schiavini, Alessia Giorgini, Alberto Colombo, Andrea Lombardi, P. Del Poggio, Franco Capra, M. Colpani, Liliana Chemello, Carlo Magni, M.A. Di Rosolini, Luisa Cavalletto, Vinicio Manfrin, Alfredo Alberti, A d'Arminio Monforte, A. Digiacomo, Paolo Grossi, Angiola Spinetti, Giancarlo Spinzi, Paolo Fabris, Clara Dibenedetto, Massimo Memoli, Alessandro Soria, Irene Cacciola, Massimo Puoti, Vincenza Calvaruso, and G. Cardaci

Subjects
chemistry.chemical_compound, medicine.medical_specialty, Hepatology, chemistry, business.industry, Ribavirin, Internal medicine, Genotype, Gastroenterology, medicine, business, Sofosbuvir/velpatasvir
Published
2019

24. Resistance test guided retreatment of HCV infected patients with a previous failure to a NS5A inhibitor-containing regimen: the Italian Vironet C real life experience

Author

Pietro Lampertico, Valeria Cento, Claudio Maria Mastroianni, M. Puoti, Giuliano Rizzardini, Maurizio Zazzi, M. Lichtner, Bianca Bruzzone, Ivana Maida, Elisabetta Degasperi, C.F. Perno, M. Rendina, Giustino Parruti, Vincenza Calvaruso, Gloria Taliani, F. Di Lorenzo, Ilaria Lenci, Anna Claudia Pellicelli, Caterina Pasquazzi, Stefania Paolucci, A. Raddi, Marianna Aragri, Ennio Polilli, Giulia Morsica, Mario Starace, M. Andreoni, M. Di Stefano, C. Minichini, L. Donnarumma, V. Guarneri, Simona Marenco, Simona Landonio, Raffaele Cozzolongo, V. Pace Palitti, N. Cuomo, P. Andreone, Nicola Coppola, Silvia Galli, Mario Angelico, C. Paternoster, Roberto Ganga, Vanni Borghi, Elisabetta Teti, Sergio Babudieri, Silvia Barbaliscia, Anna Licata, Giovanni Cenderello, Antonio Craxì, Filomena Morisco, Maurizia Rossana Brunetto, V.C. Di Maio, Vincenzo Sangiovanni, A. Ciancio, Piero Colombatto, Valeria Micheli, Teresa Pollicino, Laura Ambra Nicolini, Alessia Giorgini, Valeria Ghisetti, S. Novati, Annapaola Callegaro, Aldo Bertoli, E. Milano, Roberto Gulminetti, A. De Santis, F. Ceccherini-Silberstein, Teresa Santantonio, C. Masetti, G. Raimondo, Di Maio, V.C., Aragri, M., Masetti, C., Paolucci, S., Bruzzone, B., Degasperi, E., Barbaliscia, S., Pollicino, T., Minichini, C., Calvaruso, V., Rendina, M., Cento, V., Teti, E., Micheli, V., Ghisetti, V., Polilli, E., Palitti, V. Pace, Landonio, S., Lenci, I., Donnarumma, L., Nicolini, L.A., Bertoli, A., Starace, M., Pasquazzi, C., Callegaro, A.P., Morisco, F., Cenderello, G., Marenco, S., Gulminetti, R., Novati, S., Guarneri, V., Andreone, P., Galli, S., Ciancio, A., Sangiovanni, V., Cuomo, N., Raddi, A., Morsica, G., Borghi, V., Maida, I., Brunetto, M., Colombatto, P., Cozzolongo, R., De Santis, A., Lichtner, M., Babudieri, S., Taliani, G., Santantonio, T., Di Stefano, M., Paternoster, C., Ganga, R., Puoti, M., Rizzardini, G., Pellicelli, A., Milano, E., Mastroianni, C., Licata, A., Di Lorenzo, F., Giorgini, A., Lampertico, P., Parruti, G., Coppola, N., Zazzi, M., Raimondo, G., Andreoni, M., Craxì, A., Angelico, M., Perno, C.F., and Ceccherini-Silberstein, F.

Subjects
Resistance test, medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, DAA failur, Vironet C, NS5A, Regimen, Internal medicine, medicine, retreatment, business
Abstract

Previous article in issueNext article in issue Introduction: There is a limited documentation about the retreatment of patients failing a recommended NS5A-containing regimen in Italy. Materials & methods: Within the VIRONET-C network, 386 NS5A-failing patients infected with different HCV-genotypes (GT) (GT1a/1b/2a-c/3a-b-g-h/4a-d-n-o-v=93/124/19/112/38) were analyzed. Retreatment of 105 failures was investigated. HCV-resistance-test was performed by Sanger-sequencing. Results: Failures following seven different NS5A-containing regimens were studied: 3D/2D (paritaprevir/ombitasvir ± dasabuvir) ± ribavirin (N = 72/4), daclatasvir/ledipasvir/velpatasvir + sofosbuvir ± ribavirin (N = 105/131/20), grazoprevir/elbasvir ± ribavirin (N = 34), glecaprevir/pibrentasvir (N = 20). Notably, 18.1% of NS5A-failing patients did not show any resistance-associated-substitutions (RAS), while 81.9% showed at least one NS5A-RAS, with multiclass-resistance in 35.5%. NS5A-RAS were observed more frequently in glecaprevir/pibrentasvir failures (GT1a 83.3%: Y93H + Q30H/D or +H58D; GT3a: 83.3% Y93H + A30K/G or +L31I) compared to sofosbuvir/velpatasvir (GT1a 16.6%: Y93H + Q30H, p = 0.08; GT3a 20.0%: Y93H/N + A30K/T, p = 0.03). To date, 105 failures have started a retreatment: sofosbuvir/velpatasvir ± ribavirin (N = 30), sofosbuvir/velpatasvir/voxilaprevir ± ribavirin (N = 67), glecaprevir/pibrentasvir (N = 4), grazoprevir/elbasvir ± sofosbuvir + ribavirin (N = 3), 3D + sofosbuvir + ribavirin (N = 1). The majority of patients were cirrhotic (51.9%) and relapsers (87.5%). The prevalence of NS5A-RASs before retreatment was 80.9%, with multiclass-resistance 29.5%. Among patients completing post-retreatment follow-up, a sustained-viral-response at week 12 (SVR12) was observed in 26/33 (78.8%). SVR4 was documented in 49/56 (87.5%). SVR12 was 76.0% with sofosbuvir/velpatasvir ± ribavirin (N = 25). Differently, SVR12 was 100% with glecaprevir/pibrentasvir for 8/12/16 weeks (N = 3), grazoprevir/elbasvir ± sofosbuvir + ribavirin for 12/24 weeks (N = 3) or 3D + sofosbuvir + ribavirin for 24 weeks (N = 1), despite the presence of NS5A-RASs. Until now, 67 patients started sofosbuvir/velpatasvir/voxilaprevir ± ribavirin recommended-retreatment for 12 weeks. 54/67 (80.6%) showed at least one baseline NS5A-RAS, 23/67 (34.3%) multiple-NS5A-RASs, and 22/67 (32.8%) multiclass-resistance. Of 25 patients with available outcome, 96.0% had SVR4. Only 1 GT1b infected patient was non-responder, without RASs before retreatment. Conclusions: In this real-life setting, NS5A-RASs were frequently detected at failure, and multiclass-resistance was around 30%. Overall, SVR after resistance-test-guided retreatment was >95%, with the exception of the sofosbuvir/velpatasvir retreatment. Our results show how HCV resistance-test at failure may be useful to optimize retreatment strategies.

Published
2019

25. Efficacy and safety of Elbasvir/Grazoprevir in a large real-life cohort of HCV-infected patients

Author

Paolo Grossi, Sandro Panese, G. Cardaci, Barbara Menzaghi, Piergiorgio Scotton, Simona Landonio, Agostino Colli, Massimo Zuin, Caterina Uberti-Foppa, Francesco Russo, M. Colpani, Mauro Viganò, Alessia Giorgini, Maria Cristina Rossi, Elisabetta Degasperi, Serena Zaltron, Francesco Castelli, Massimo Memoli, Andrea Gori, Roberta Soffredini, Franco Noventa, S. Lobello, Ombretta Spinelli, Alessandro Soria, A d'Arminio Monforte, Luisa Pasulo, Vinicio Manfrin, Elisabetta Buscarini, Angelo Pan, Monica Schiavini, Maria Grazia Rumi, P. Del Poggio, Alberto Colombo, Valter Vincenzi, Giancarlo Spinzi, Franco Capra, Massimo Puoti, Roberto Gulminetti, Valentina Zuccaro, Stefano Fagiuoli, Alfredo Alberti, Martina Gambato, Luisa Cavalletto, F. Cattelan, Pietro Lampertico, I. Franceschet, Alessio Aghemo, Marie Graciella Pigozzi, L. Comi, Giada Carolo, Liliana Chemello, Veronica Paon, Paolo Sacchi, Andrea Capretti, Maria Cristina Vinci, Roberta D'Ambrosio, Monia Mendeni, Maurizio Carrara, Paolo Fabris, Angiola Spinetti, and Clara Dibenedetto

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Cohort, Gastroenterology, Medicine, Elbasvir, Grazoprevir, business
Published
2019

26. Multifactor risk evaluation in patients who have eradicated HCV infection: an interim analysis in the PITER cohort

Author

Alessandra Orlandini, Vincenza Calvaruso, Valentina Cossiga, Monica Monti, D.C. Amoruso, Andrea Iannone, A.R. Buonomo, S. Labanca, Roberta D'Ambrosio, A. Ciaccio, Giuseppina Brancaccio, Mario Masarone, Elisa Biliotti, Alessandro Soria, Chiara Baiguera, Maria Elena Tosti, Roberto Filomia, Barbara Coco, Homie Razavi, F. Baragli, Michele Quaranta, Stefano Rosato, M. Cannizzaro, C. Eleonora, Chris Estes, Marcello Dallio, Luigina Ferrigno, Loreta A. Kondili, M. Loi, V. Guarnieri, A. Ciancio, Maria Cristina Vinci, Romina Corsini, Alberto Zanetto, M. Siciliano, D. Ieluzzi, Alessia Giorgini, Savino Bruno, and L. E. Weimer

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Cohort, Medicine, In patient, Interim analysis, business, Risk evaluation
Published
2018

27. SVR is the strongest predictor of occurrence and recurrence of hepatocellular carcinoma in HCV cirrhotic patients after treatment with direct acting antivirals: A prospective multicenter Italian study

Author

Andrea Aglitti, Fabio Conti, M. Rendina, A. Di Leo, A. Ciancio, Elisabetta Degasperi, L. Marzi, P. Andreone, Massimo Zuin, S. Bruno, Pietro Lampertico, Simona Bollani, Alessio Aghemo, Maurizia Rossana Brunetto, Vincenza Calvaruso, Ana Lleo, Patrick Maisonneuve, Erica Villa, Alessia Giorgini, Marcello Persico, V. Boccaccio, Barbara Coco, Giulia Troshina, and V. Di Marco

Subjects
Oncology, medicine.medical_specialty, Hepatology, business.industry, Hepatocellular carcinoma, Internal medicine, Gastroenterology, medicine, business, medicine.disease, DIRECT ACTING ANTIVIRALS, After treatment
Published
2018

28. THU-131-Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir for retreatment of chronic hepatitis C patients with a previous failure to direct-acting antivirals: A real-life study from the NAVIGATORE Lombardia and Veneto Networks

Author

Sara Piovesan, Franco Noventa, Pietro Lampertico, Antonio Carlotto, Paolo Bonfanti, Alessio Aghemo, Canio Carriero, Alessandro Soria, Simona Landonio, Pierangelo Rovere, Filippo Viviani, Angiola Spinetti, Alessia Giorgini, Roberta Soffredini, Maurizio Carrara, Alessia Zoncada, Lorenzo Morini, Pietro Pozzoni, Federico Gatti, Giada Carolo, Franco Capra, Elisabetta Degasperi, Pier Giorgio Scotton, Maria Cristina Vinci, Andrea Lombardi, Paolo Angeli, Riccardo Centenaro, Luisa Pasulo, Alfredo Alberti, Franco Maggiolo, Massimo Puoti, Stefano Fagiuoli, Francesco Russo, and Stefania Paolucci

Subjects
medicine.medical_specialty, Hepatology, Chronic hepatitis, business.industry, Medicine, business, Intensive care medicine, DIRECT ACTING ANTIVIRALS, Life study, Sofosbuvir / velpatasvir / voxilaprevir
Published
2019

29. THU-180-Treatment of genotype 3 HCV infection in the large real-life 'Navigatore Lombardia' multicentre cohort: Results from three different regimens

Author

Maria Grazia Rumi, Mauro Viganò, Alberto Colombo, Sherrie Bhoori, Antonella d'Arminio Monforte, Riccardo Centenaro, Luisa Pasulo, Sergio Lazzaroni, Alessandro Soria, Andrea Capretti, Maria Cristina Vinci, Pietro Lampertico, Gianpiero Aimo, Chiara Molteni, Andrea Lombardi, Alessio Aghemo, Silvia Polo, Alessia Giorgini, Federico Gatti, Paola Brambilla, Elisabetta Degasperi, E. Dionigi, Anna Spolti, Paolo Bonfanti, Anna De Bona, Luca Valenti, Stefania Salpietro, Marta Borghi, Esther Merlini, Natalia Terreni, Giuliano Rizzardini, Valentina Grasso, Paolo Viganò, Sara Gritti, Paolo Grossi, Roberta D'Ambrosio, Simona Landonio, Alessandra Gambaro, Daniele Bella, Massimo Puoti, Ombretta Spinelli, Caterina Uberti-Foppa, Angelo Pan, Monica Schiavini, Mariella Di Marco, Paolo Poggio, Barbara Menzaghi, Canio Carriero, Hamid Hasson, Elisa Colella, Roberto Boldizzoni, Nunzia Bottalico, Stefano Fagiuoli, Angiola Spinetti, Cecilia Liani, Giuseppe Lapadula, Guido Colloredo Mels, Massimo Graffeo, Franco Noventa, Luciana Scabeni, Roberta Soffredini, Roberto Gulminetti, Marie Graciella Pigozzi, and Isabella Carderi

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Diabetes mellitus, Cohort, Genotype, Medicine, business, medicine.disease
Published
2019

30. Effectiveness and safety of Sofosbuvir/Velpatasvir/Voxilaprevir for retreatment of chronic hepatitis C patients with a previous failure to direct-acting antivirals: a real-life study from the Navigatore Lombardia and Veneto Networks

Author

Pietro Pozzoni, Maria Cristina Vinci, Andrea Lombardi, Pietro Lampertico, Paolo Angeli, Alessio Aghemo, M. Puoti, F. Maggiolo, A. Carlotto, Simona Landonio, Sara Piovesan, Francesca Gatti, P. Scotton, Francesco Russo, Angiola Spinetti, Stefania Paolucci, Giada Carolo, Franco Noventa, Franco Capra, Stefano Fagiuoli, P.A. Rovere, Lorenzo Morini, Alessia Giorgini, P. Bonfanti, C. Carriero, F. Viviani, Elisabetta Degasperi, A. Zoncada, Roberta Soffredini, Riccardo Centenaro, Luisa Pasulo, Alfredo Alberti, Alessandro Soria, and Maurizio Carrara

Subjects
medicine.medical_specialty, Hepatology, Chronic hepatitis, business.industry, Gastroenterology, Medicine, business, Intensive care medicine, Life study, DIRECT ACTING ANTIVIRALS, Sofosbuvir / velpatasvir / voxilaprevir
Published
2019

31. Multiclass HCV resistance to interferon-free direct acting antivirals regimens in real life failures advocates for tailored second-line therapies

Author

Ilaria Lenci, A. Di Biagio, Giuliano Rizzardini, L. Marinaro, C. D'Ambrosio, Fausto Baldanti, Ivana Maida, G.B. Gaeta, M. Puoti, T. Ruggiero, Mario Angelico, Vincenza Calvaruso, Laura Sticchi, Mario Starace, Giustino Parruti, P. Cacciatore, Nicola Caporaso, Caterina Pasquazzi, Stefania Paolucci, Anna Claudia Pellicelli, M. Andreoni, C. Masetti, Sergio Babudieri, Gabriella d'Ettorre, Francesco Santopaolo, Raffaele Cozzolongo, P. Andreone, Carlo Magni, Valeria Cento, Guido Gubertini, J. Vecchiet, Stefano Novati, Nicola Coppola, C.F. Perno, Bianca Bruzzone, F. De Leonardis, V. Pace Palitti, Marianna Aragri, A. Grieco, Pierluigi Tarquini, G. De Stefano, G. Raimondo, Teresa Pollicino, Alessia Giorgini, Giorgio Barbarini, Valeria Ghisetti, G. Verucchi, M.C. Sorbo, Savino Bruno, M. Paoloni, F. Ceccherini-Silberstein, Roberto Gulminetti, Antonio Craxì, Filomena Morisco, Manuela Merli, V.C. Di Maio, Vincenzo Sangiovanni, A. Ciancio, Simona Francioso, Simona Landonio, Aldo Bertoli, A. Mancon, Valeria Micheli, Antonio Picciotto, V. Boccaccio, M. Melis, Ennio Polilli, F.P. Antonucci, Dante Romagnoli, and Silvia Barbaliscia

Subjects
Oncology, medicine.medical_specialty, Hepatology, business.industry, Interferon free, Gastroenterology, DIRECT ACTING ANTIVIRALS, 03 medical and health sciences, 0302 clinical medicine, Second line, 030220 oncology & carcinogenesis, Internal medicine, Medicine, In real life, 030211 gastroenterology & hepatology, business
Published
2017

32. Multiclass hepatitis C virus resistance to direct acting antivirals in real life interferon-free regimens failures advocates for tailored second-line therapies

Author

A. Grieco, Valeria Cento, Savino Bruno, M. Paoloni, Anna Claudia Pellicelli, Gabriella d'Ettorre, Raffaele Cozzolongo, G.D. Stefano, Carlo Magni, V. Boccaccio, M. Andreoni, Fausto Baldanti, Silvia Barbaliscia, J. Vecchiet, Valeria Micheli, Antonio Picciotto, Giustino Parruti, Guido Gubertini, M. Melis, Pierluigi Tarquini, Francesca Ceccherini-Silberstein, Bianca Bruzzone, Sergio Babudieri, Antonio Di Biagio, M. Puoti, Manuela Merli, L. Marinaro, Mario Starace, Caterina Pasquazzi, Marianna Aragri, Antonio Craxì, Teresa Pollicino, Filomena Morisco, V.C. Di Maio, Alessia Giorgini, Vincenzo Sangiovanni, Giorgio Barbarini, Valeria Ghisetti, G. Verucchi, T. Ruggiero, Ivana Maida, P. Andreone, Vincenza Calvaruso, Giovanni Raimondo, C. D'Ambrosio, Simona Francioso, F.P. Antonucci, Dante Romagnoli, C.F. Perno, Mario Angelico, Ilaria Lenci, Alessia Ciancio, Roberto Gulminetti, G.B. Gaeta, Simona Landonio, Nicola Caporaso, Francesco Santopaolo, Nicola Coppola, Laura Sticchi, Valeria Pace Palitti, Stefania Paolucci, Aldo Bertoli, and A. Mancon

Subjects
0301 basic medicine, Hepatology, business.industry, Hepatitis C virus, Interferon free, medicine.disease_cause, DIRECT ACTING ANTIVIRALS, Virology, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Second line, medicine, In real life, 030211 gastroenterology & hepatology, business
Published
2017

33. Effectiveness and safety of simeprevir-based regimens for hepatitis C in Italy

Author

Hamid Hasson, Maria Palma, Alessia Giorgini, Giovanni Battista Gaeta, Alessio Aghemo, Gianpiero D'Offizi, Roberta Termini, Barbara Menzaghi, Giuseppina Brancaccio, Gaeta, Giovanni Battista, Aghemo, Alessio, Menzaghi, Barbara, D'Offizi, Gianpiero, Giorgini, Alessia, Hasson, Hamid, Brancaccio, Giuseppina, Palma, Maria, and Termini, Roberta

Subjects
Adult, Male, Simeprevir, medicine.medical_specialty, Sustained Virologic Response, Sofosbuvir, Liver Cirrhosi, Hepatitis C virus, medicine.disease_cause, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Ribavirin, Clinical endpoint, Medicine, 030212 general & internal medicine, Aged, Antiviral Agent, Hepaciviru, business.industry, General Medicine, Hepatitis C, Middle Aged, medicine.disease, Regimen, Treatment Outcome, Italy, Tolerability, chemistry, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Cohort Studie, business, Human, medicine.drug
Abstract

The combination of the direct-acting antivirals, simeprevir (SMV) and sofosbuvir (SOF), was the first highly efficacious interferon-free combination for treating patients with hepatitis C virus (HCV), and was widely used in Italy as a result. The aim of this study was to evaluate effectiveness and safety of SMV in Italian patients with HCV genotype (GT) 1 and 4 overall, by treatment regimen [SMV/SOF and SMV/SOF+ribavirin (RBV)], cirrhosis status, and GT (GT1a, GT1b, and GT4). An observational multicenter cohort study was conducted in 46 centers across Italy. Adult HCV + GT1 or GT4 patients, naive or treatment-experienced, with or without cirrhosis, who underwent treatment with a SMV-containing regimen from May to September 2015 were included. The primary endpoint was sustained virologic response (SVR), defined as undetectable serum HCV RNA levels 12 weeks after treatment end (SVR12). The secondary endpoints included duration of treatment, safety and tolerability of each treatment regimen, and SVR by treatment and according to response to previous treatment and fibrosis stage. The association between SVR and a subset of the most clinically relevant variables was investigated by a multivariate logistic regression analysis. A total of 349 HCV-positive patients treated with an SMV-based regimen were enrolled, of whom 342 received SMV/SOF ± RBV and were included in this analysis. Most patients (59.4%) were treatment-experienced and had cirrhosis (78.1%). In the group receiving SMV/SOF + RBV, most (63.1%) were treatment-experienced and 82.9% had cirrhosis. Three patients were lost to follow-up; 330 patients receiving SMV/SOF ± RBV (96.5%) were treated for 12 weeks. Overall, SVR12 was achieved by 324 patients [94.2%, 95% confidence interval (95% CI) 92–97]. When stratified by treatment and clinical and virologic characteristics, SVR12 was achieved by 77 of 79 [97.5% (95% CI 94.0–100.0)] and 247 of 263 [93.9% (95% CI 91.0–96.8)] patients receiving SMV/SOF and SMV/SOF + RBV, respectively; 132 of 139 (95.0%) naive versus 192/203 (94.6%) treatment-experienced patients; 250 of 267 (93.6%) cirrhotic and 56 of 62 (90.3%) HIV coinfected patients. SMV-based regimens were generally well tolerated. Adverse events leading to treatment discontinuations were not observed. A high proportion of patients treated with SMV/SOF-based regimens achieved SVR12 in this study. A high SVR12 rate was also achieved in patients with cirrhosis, treatment experience, and HUV coinfected patients.

Published
2018

34. SVR is the strongest predictor of occurrence and recurrence of hepatocellular carcinoma in HCV cirrhotic patients after treatment with DAAs: a prospective multi-centric Italian study

Author

Vincenza Calvaruso, V. Boccaccio, Pietro Lampertico, Patrick Maisonneuve, Alessio Aghemo, Alessia Giorgini, Giulia Troshina, Elisabetta Degasperi, V. Di Marco, Fabio Conti, Ana Lleo, Maurizia Rossana Brunetto, Massimo Zuin, Simona Bollani, P. Andreone, A. Di Leo, L. Marzi, Barbara Coco, Erica Villa, Marcello Persico, S. Bruno, M. Rendina, Andrea Aglitti, and A. Ciancio

Subjects
medicine.medical_specialty, Hepatology, business.industry, medicine.disease, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Hepatocellular carcinoma, medicine, 030211 gastroenterology & hepatology, business, After treatment
Published
2018

35. Real-life effectiveness and safety of Glecaprevir/Pibrentasvir among 723 Italian patients with chronic hepatitis C: The Navigator-II study

Author

Clara Dibenedetto, Caterina Uberti-Foppa, Monica Schiavini, P. Del Poggio, Marie Graciella Pigozzi, Paolo Viganò, M.G. Rumi, Riccardo Centenaro, Luisa Pasulo, Marta Borghi, Barbara Menzaghi, Pietro Lampertico, Andrea Capretti, Maria Cristina Vinci, Alessio Aghemo, Carlo Magni, Elisabetta Buscarini, Massimo Zuin, Angelo Pan, A d'Arminio Monforte, Sergio Lazzaroni, Angiola Spinetti, Omar Giglio, Alessia Giorgini, A. Colli, Lorenzo Morini, M. Colpani, Giancarlo Spinzi, Roberta D'Ambrosio, Alessandro Soria, Alberto Colombo, M. Puoti, Ombretta Spinelli, Andrea Gori, Franco Noventa, Stefano Fagiuoli, F. Maggiolo, and Roberta Soffredini

Subjects
030213 general clinical medicine, 03 medical and health sciences, medicine.medical_specialty, 0302 clinical medicine, Hepatology, Chronic hepatitis, business.industry, Internal medicine, medicine, 030211 gastroenterology & hepatology, Glecaprevir / pibrentasvir, business
Published
2018

36. Treatment with PEG-interferon and Ribavirin for Chronic Hepatitis C Increases Neutrophil and Monocyte Chemotaxis

Author

Carlo Selmi, Mauro Podda, M. Eric Gershwin, Franco Capsoni, Federica Malinverno, A. M. Ongari, Massimo Zuin, Alessia Giorgini, A. Benetti, Pier Maria Battezzati, Ana Lleo, and Lorenzo Rossaro

Subjects
Adult, Male, Time Factors, Monocyte chemotaxis, Neutrophils, Macrophage-1 Antigen, Enzyme-Linked Immunosorbent Assay, Interferon alpha-2, Biology, Neutropenia, Antiviral Agents, Monocytes, General Biochemistry, Genetics and Molecular Biology, Polyethylene Glycols, Leukocyte Count, chemistry.chemical_compound, Phagocytosis, History and Philosophy of Science, Pegylated interferon, Interferon, Granulocyte Colony-Stimulating Factor, Ribavirin, medicine, Humans, Aged, Cell chemotaxis, CD11b Antigen, General Neuroscience, Granulocyte-Macrophage Colony-Stimulating Factor, Interferon-alpha, Bacterial Infections, Hepatitis C, Hepatitis C, Chronic, Middle Aged, Flow Cytometry, medicine.disease, Recombinant Proteins, Chemotaxis, Leukocyte, chemistry, Immunology, Absolute neutrophil count, Female, Reactive Oxygen Species, medicine.drug
Abstract

The incidence of infections increases during treatment with pegylated interferon (PEG-IFN) and ribavirin (RBV) for chronic hepatitis C (CHC). Despite a reduction in neutrophil count, there is no clear relationship between infection occurrence and neutropenia. In the present study we investigated whether HCV treatment alters leukocyte function. We studied cell chemotaxis, reactive oxygen species, neutrophil phagocytosis, CR3 expression, and plasma colony stimulating factors (CSF) in 20 healthy subjects and 20 patients with CHC (10 with cirrhosis) at baseline, during antiviral treatment (at 4, 12, 24 weeks), and 12 weeks after discontinuation. Our results demonstrate that neutrophil chemotaxis and oxidative burst significantly increased during treatment and returned to baseline at the end of therapy. CR3 neutrophil expression was enhanced in baseline CHC compared to controls but did not change during antiviral treatment. Chemotaxis, oxidative burst, phagocytosis, and CSF levels did not differ significantly between patients before treatment and control subjects or among CHC cases according to the presence of cirrhosis in either cell subpopulation. In conclusion, the innate immune cell activity is enhanced in patients with CHC during antiviral treatment and returns to normal after its discontinuation thus possibly playing a role in their susceptibility to infections.

Published
2009

37. Helicobacter pylori infection in hepatic encephalopathy: Relationship to plasma endotoxins and blood ammonia

Author

Reda Badr, Ali Zaki, Mahmoud Lotfy, Mohamed El-Sayed, Hassan Abdel-Hady, Carlo Selmi, Gamal Badra, and Alessia Giorgini

Subjects
medicine.medical_specialty, Helicobacter pylori infection, Cirrhosis, Hepatology, Biology, Helicobacter pylori, medicine.disease, biology.organism_classification, Gastroenterology, Liver disease, Infectious Diseases, Internal medicine, Ascites, medicine, Arterial blood, Blood ammonia, medicine.symptom, Hepatic encephalopathy
Abstract

Background/Aim: Hepatic encephalopathy (HE) is frequently observed in patients with advanced liver disease and manifests a wide variety of neuropsychiatric signs and symptoms. Ammonia toxicity and bacterial endotoxins have been suggested as key determinants of HE onset whereas a role for Helicobacter pylori infection has not been established. We investigated the correlation between H. pylori infection and HE severity (evaluated through functional tests) in 60 outpatients with established liver cirrhosis and 20 non-cirrhotic controls. Methods: Fasting arterial blood ammonia, plasma endotoxins, and H. pylori infection status were investigated in all subjects. Results: H. pylori infection was documented in 35/60 (58%) patients and in 6/20 (30%) controls (P = 0.039). Significant differences were observed between patients with and withoutHE for age, presence of ascites, fasting arterial blood ammonia, plasma endotoxin, and H. pylori infection. Further, a significant increase in fasting arterial blood ammonia and plasma endotoxin was associated with H. pylori infection in cirrhotic patients. Last, medical treatment of H. pylori infection led to a significant decrease in HE severity and fasting arterial blood ammonia levels. Conclusion: In conclusion, we submit that H. pylori infection might, in fact, play a role in increasing the circulating levels of ammonia and endotoxins in cirrhotic patients, thus facilitating the onset of HE.

Published
2007

38. Effectiveness of Simeprevir Treatment for Hepatitis C in Real Practice: Preliminary Results from the Stily Italian Observational Study

Author

Gianpiero D'Offizi, Alessia Giorgini, Barbara Menzaghi, Sergio Babudieri, Maurizia Rossana Brunetto, Adriano Lazzarin, Roberta Termini, M. Palma, L. Simoni, G.B. Gaeta, and Stefano Fagiuoli

Subjects
Simeprevir, Pediatrics, medicine.medical_specialty, Hepatology, business.industry, Hepatitis C, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, 030220 oncology & carcinogenesis, Medicine, 030211 gastroenterology & hepatology, Observational study, business
Published
2016

39. Acute liver and renal failure during treatment with buprenorphine at therapeutic dose

Author

Massimo Zuin, Alessia Giorgini, Andrea Crosignani, Pietro Invernizzi, Pier Maria Battezzati, Carlo Selmi, Claudio A. Cocchi, A. Benetti, and Mauro Podda

Subjects
Adult, Male, Cirrhosis, Hepatology, CYP3A4, Heroin Dependence, business.industry, Narcotic Antagonists, Hepatitis C virus, Gastroenterology, Acute Kidney Injury, Liver Failure, Acute, Pharmacology, medicine.disease, medicine.disease_cause, Buprenorphine, Nephrotoxicity, Mitochondrial toxicity, Therapeutic index, medicine, Humans, business, Pharmacogenetics, medicine.drug
Abstract

Buprenorphine is a semi-synthetic opioid derivative commonly used in the treatment of heroin addiction. Life-threatening complications have been described following overdoses while few cases of hepatotoxicity due to drug use at therapeutic doses have been recently described in hepatitis C virus carriers. In these cases, however, histological assessment was not exhaustive and no extra-hepatic organ failure was observed. We describe herein a case of acute liver and kidney failure in a patient with previously latent hepatitis C virus chronic infection following recommended doses of buprenorphine. Histology did not demonstrate any feature compatible with hepatitis C virus reactivation or liver cirrhosis and suspension of the treatment led to the resolution of both liver and kidney failure. Causality criteria fulfillment indicates a high probability of buprenorphine-induced liver toxicity. No signs of pre-existant kidney impairment or of pre- or post-renal causes were observed. Since buprenorphine is metabolized through cytochrome P450 3A4, we genotyped six genetic polymorphisms previously described in poor metabolizers but could not confirm these pharmacogenetic bases in this case. In conclusion, we surmise that buprenorphine at suggested doses can induce liver and kidney failure in susceptible individuals, possibly through direct mitochondrial toxicity.

Published
2009

40. A multicentre prospective study response to treatment in genotype 3 and 1b infected patients with sickest liver cirrhosis: SVR 4 is not a reliable measure

Author

M. Rendina, Alessia Giorgini, A. Ciancio, Maurizia Rossana Brunetto, Simona Bollani, Massimo Zuin, S. Bruno, Andrea Aglitti, Fabio Conti, P. Andreone, Erica Villa, Marcello Persico, Ana Lleo, V. Di Marco, Y. Toshina, Alessio Aghemo, Vincenza Calvaruso, A. Di Leo, S. De Nicola, Barbara Coco, and L. Marzi

Subjects
medicine.medical_specialty, Cirrhosis, Hepatology, business.industry, Gastroenterology, Measure (physics), medicine.disease, Response to treatment, Internal medicine, Genotype, medicine, business, Prospective cohort study
Published
2016

41. Primary biliary cirrhosis: solving the enigma

Author

Carlo Selmi, Massimo Zuin, Pietro Invernizzi, Alessia Giorgini, Mauro Podda, and M. Eric Gershwin

Subjects
Pathology, medicine.medical_specialty, Cirrhosis, T-Lymphocytes, Intrahepatic bile ducts, Autoimmunity, Disease, Biology, medicine.disease_cause, General Biochemistry, Genetics and Molecular Biology, Pathogenesis, Major Histocompatibility Complex, Primary biliary cirrhosis, History and Philosophy of Science, medicine, Genetic predisposition, Humans, Chromosomes, Human, X, Liver Cirrhosis, Biliary, General Neuroscience, Epithelial Cells, medicine.disease, Immunoglobulin A, Mitochondria, Molecular mimicry, Haplotypes, Antibodies, Antinuclear, Immunology
Abstract

Primary biliary cirrhosis (PBC) is a chronic cholestatic liver disease, most commonly affecting female patients between 40 and 60 years of age. Patient sera present autoantibodies against mitochondrial antigens (AMA) and elevated serum IgM. Histologic studies demonstrate progressive destruction of small- and medium-sized intrahepatic bile ducts and, ultimately, liver cirrhosis. The precise mechanisms leading to selective destruction of such biliary epithelial cells are still unknown, although a number of immunomediated pathways have been proposed. Genetic background is critical in determining susceptibility to the disease, although no clear association with haplotypes of the major histocompatibility complex has been identified. Molecular mimicry by either infectious agents or xenobiotics has been proposed as a means of breaking tolerance in genetically predisposed individuals, thus leading to the onset of PBC. In this review, available data and current theories regarding the immunomediated pathogenesis of PBC will be described.

Published
2005

42. T-12 Tenofovir suppressed viral suppression in most field practice, treatment-naïve patients with CHB followed for 3 years in a multicenter European study

Author

Giancarlo Spinzi, Carlo Magni, M. Strazzabosco, Fabio Facchetti, Georgios Papatheodoridis, Ernesto Minola, Stefano Fagiuoli, Maria Cristina Vinci, R. Esteban, Massimo Zuin, E. Angeli, Cihan Yurdaydin, T. Santantonio, Serena Zaltron, G. Pinzello, Mauro Viganò, A. Colli, S. Bruno, Alessia Giorgini, A. Salmi, María Isabel Colombo, Giuliano Rizzardini, G. Carosi, F. Fumagalli Maldini, P. Del Poggio, O. Fracassetti, Roberta Soffredini, Massimo Fasano, Natalia Terreni, Giorgio Bellati, Ekaterini Margariti, Luisa Pasulo, Ramazan Idilman, M. Buti, Silvia Colombo, M. Andreoletti, M. Milanese, A. Vavassori, Pietro Lampertico, Guido Gubertini, Alberto Colombo, and Federica Invernizzi

Subjects
Oncology, medicine.medical_specialty, Pediatrics, Hepatology, Tenofovir, business.industry, Gastroenterology, Therapy naive, Field practice, Internal medicine, medicine, Viral suppression, business, medicine.drug
Published
2013

43. T-9 2-year effectiveness and safety of tenofovir in 302 NUC-naive patients with chronic hepatitis B: a multicenter European study in clinical practice

Author

Alberto Colombo, Stefano Fagiuoli, Ramazan Idilman, Roberta Soffredini, M. Buti, Serena Zaltron, Federica Invernizzi, Alessia Giorgini, Maria Cristina Vinci, Natalia Terreni, E. Angeli, Georgios Papatheodoridis, A. Salmi, Carlo Magni, Massimo Zuin, Giuliano Rizzardini, Fabio Facchetti, M. Andreoletti, G. Carosi, F. De Filippi, R. Esteban, María Isabel Colombo, A. Colli, Cihan Yurdaydin, G. Pinzello, F. Fumagalli Maldini, T. Santantonio, S. Bruno, M. Milanese, A. Vavassori, Massimo Fasano, Ernesto Minola, P. Del Poggio, Mauro Viganò, Luisa Pasulo, Pietro Lampertico, K. Margariti, Guido Gubertini, Giorgio Bellati, and Giancarlo Spinzi

Subjects
Clinical Practice, Therapy naive, medicine.medical_specialty, Hepatology, Tenofovir, Chronic hepatitis, business.industry, Internal medicine, Gastroenterology, medicine, business, medicine.drug
Published
2012

44. 731 EFFECTIVENESS AND SAFETY OF TENOFOVIR DISOPROXIL FUMARATE IN FIELD PRACTICE: A MULTICENTER EUROPEAN COHORT STUDY OF 302 NUC-NAIVE PATIENTS WITH CHRONIC HEPATITIS B

Author

A. Salmi, Roberta Soffredini, R. Esteban, Natalia Terreni, Giorgio Bellati, Alessia Giorgini, Giancarlo Spinzi, Ernesto Minola, Georgios Papatheodoridis, M. Milanese, A. Vavassori, T. Santantonio, Serena Zaltron, F. Fumagalli Maldini, G. Pinzello, Stefano Fagiuoli, E. Angeli, Giuliano Rizzardini, Pietro Lampertico, Cihan Yurdaydin, Alberto Colombo, Carlo Magni, K. Margariti, Massimo Zuin, Savino Bruno, Maria Cristina Vinci, Ramazan Idilman, Federica Invernizzi, A. Colli, M. Buti, Guido Gubertini, P. Del Poggio, M. Andreoletti, María Isabel Colombo, F. De Filippi, Mauro Viganò, Fabio Facchetti, Luisa Pasulo, and Massimo Fasano

Subjects
Therapy naive, medicine.medical_specialty, Hepatology, Chronic hepatitis, Tenofovir, Field practice, business.industry, Internal medicine, medicine, business, Cohort study, medicine.drug
Published
2011

45. Four years of tenofovir monotherapy for NUC naïve field practice European patients suppresses HBV replication in most patients with a favorable renal safety profile but does not prevent HCC in patients with or without cirrhosis

Author

Alberto Colombo, Marco Rizzi, M. Colombo, Silvia Colombo, M. Andreoletti, Floriana Facchetti, E. Angeli, Roberta Soffredini, Serena Zaltron, Mauro Viganò, Francesco Castelli, Federica Invernizzi, Giorgio Bellati, Teresa Santantonio, R. Esteban, Stefano Fagiuoli, M. Milanese, A. Salmi, Maria Cristina Vinci, Mario Strazzabosco, Giuliana Cologni, Cihan Yurdaydin, Maria Buti, A. Colli, Luisa Pasulo, Giancarlo Spinzi, O. Fracassetti, Pietro Lampertico, A. Vavassori, Giuliano Rizzardini, Ramazan Idilman, Eliseo Minola, Guido Gubertini, Alessia Giorgini, Carlo Magni, Massimo Zuin, Aikaterini Margariti, P. Del Poggio, Savino Bruno, G. Mangia, Massimo Fasano, George V. Papatheodoridis, Luca S. Belli, Natalia Terreni, and M.G. Rumi

Subjects
medicine.medical_specialty, Cirrhosis, Hepatology, Tenofovir, business.industry, Gastroenterology, Hbv replication, medicine.disease, Surgery, Safety profile, Field practice, Internal medicine, medicine, In patient, business, medicine.drug
Published
2014

46. 525 TENOFOVIR MONOTHERAPY FOR NAÏVE PATIENTS WITH CHRONIC HEPATITIS B: A MULTICENTER EUROPEAN STUDY IN CLINICAL PRACTICE IN 302 PATIENTS FOLLOWED FOR 30 MONTHS

Author

F. Fumagalli Maldini, Federica Invernizzi, M. Ekaterini, Georgios Papatheodoridis, Massimo Zuin, Massimo Fasano, G. Pinzello, M. Milanese, A. Vavassori, Giorgio Bellati, T. Santantonio, A. Salmi, Carlo Magni, A. Colli, Alberto Colombo, Serena Zaltron, María Isabel Colombo, Roberta Soffredini, P. Del Poggio, R. Esteban, Maria Cristina Vinci, S. Bruno, Natalia Terreni, Ernesto Minola, Stefano Fagiuoli, Mauro Viganò, Giuliano Rizzardini, Cihan Yurdaydin, M. Andreoletti, Alessia Giorgini, G. Carosi, F. De Filippi, Ramazan Idilman, M. Buti, Luisa Pasulo, Pietro Lampertico, Guido Gubertini, E. Angeli, Fabio Facchetti, and Giancarlo Spinzi

Subjects
Clinical Practice, Therapy naive, Pediatrics, medicine.medical_specialty, Hepatology, Chronic hepatitis, Tenofovir, business.industry, medicine, business, medicine.drug
Abstract

Pinzello8, Alessia M. Giorgini9, Massimo Zuin9, Andrea Salmi10, Paolo Del Poggio11, Francesca De Filippi12, Savino Bruno12, Luisa Pasulo13, Stefano Fagiuoli13, Marco Andreoletti14, Agostino Colli14, Francesco Fumagalli Maldini15, Maria Milanese15, Alberto Eraldo Colombo16, Giorgio Bellati16, Elena Angeli17, Carlo Magni17, Guido A. Gubertini17, Giuliano Rizzardini17, Massimo Fasano18, Teresa Santantonio19, Natalia M. Terreni20, Giancarlo Spinzi20, Floriana Facchetti1, Federica Invernizzi1, Massimo Colombo1 Tenofovir monotherapy for naive patients with chronic hepatitis B: a multicenter European study in clinical practice in 302 patients followed for 30 months

Published
2012

49. Bone metabolism disease in primary bilary cirrhosis: a longitudinal study

Author

A. Benetti, Pietro Invernizzi, Andrea Crosignani, C. Squarcia, Massimo Zuin, M. Podda, P.M. Battezzati, Alessia Giorgini, and M. Gallazzi

Subjects
Longitudinal study, Bilary cirrhosis, medicine.medical_specialty, Primary (chemistry), Hepatology, business.industry, Internal medicine, Medicine, Disease, business, Gastroenterology, Bone remodeling
Published
2001

50. Gastrointestinal tolerability of ibuprofen administered in two pharmaceutical formulations

Author

Mauro Podda, Carlo Selmi, Giovanna Mandelli, Anna Cristina Sacchetta, Carlo Candiani, Alessia Giorgini, P. Zermiani, and Massimo Zuin

Subjects
Adult, Male, Sucrose, Gastrointestinal Diseases, Analgesic, Ibuprofen, Pharmacology, Permeability, Intestinal mucosa, Pharmacokinetics, Drug Discovery, Humans, Medicine, Mannitol, Antipyretic, Intestinal Mucosa, Cross-Over Studies, biology, business.industry, Anti-Inflammatory Agents, Non-Steroidal, Middle Aged, biology.organism_classification, Enteric coating, Lactulose, Tolerability, Gastric Mucosa, Occult Blood, Pyrosis, Female, business, medicine.drug
Abstract

Ibuprofen (CAS 15687-27-1) is a nonsteroidal antiinflammatory drug endowed with analgesic, antiinflammatory and antipyretic activity. The main side effect of ibuprofen and nonsteroidal antiinflammatory agents is addressed to disturbances of the gastrointestinal tract, like gastric pyrosis, gastric and intestinal damage. A pharmaceutical formulation of ibuprofen in fast melting tablets consisting in gastroprotected microgranules to be ingested without concomitant water intake (Cibalginadue Fast, hereinafter referred to as test) was compared in this trial with a formulation of ibuprofen in tablets (reference) on 18 healthy volunteers in terms of gastrointestinal and general tolerability. Both the formulations are present on the market. The two formulations were administered according to a two-period, two-formulation, two-sequence, cross-over design in repeated dose regimen to steady state with wash-out. The dose was 400 mg (2 strengths) b.i.d. over 7 days. Before, during and after each study period general tolerability was carefully checked from blood/urine biochemical parameters, adverse events experienced and vital signs. The target parameters were the gastric permeability to sucrose and the intestinal permeability to lactulose and mannitol, which were administered orally and assayed in the urine excreted during a 6-h period. Urinary excretion > 0.15% of sucrose and > 0.04 of the lactulose to mannitol ratio are considered expression of increased gastric and intestinal permeability, respectively. Three volunteers treated with the reference showed an increased gastric permeability > 0.15%. Neither other gastric nor intestinal increased permeability was detected. Occult blood in faeces was negative in all the cases. The incidence of adverse effects experienced was higher with the reference (9 volunteers) than with the test (5 volunteers). In details gastric pyrosis was experienced by six volunteers treated with the reference and only by two volunteers treated with the test. The whole tolerability was better with the test formulation than with the reference, even if these differences did not reach any statistically significant degree. The better tolerability of the test was attributed to its gastroprotection.

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